FDA 510(k) Applications for Medical Device Product Code "FXX"
(Mask, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K202598 | 3A Medical Products Co., Ltd | 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Le | 05/06/2021 |
| K955382 | 3M COMPANY | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 | 05/01/1996 |
| K180874 | 3M Health Care | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | 07/31/2018 |
| K191355 | 3M Health Care | 3MÖ High Fluid-Resistant Surgical Mask and 3MÖ High Fluid-Resistant Procedure Mask | 09/11/2019 |
| K031353 | A PLUS INTERNATIONAL, INC | SOLUTION FACE MASKS | 06/19/2003 |
| K213001 | A Plus International, Inc. | Procedure Mask, Surgical Mask | 05/11/2022 |
| K051291 | A.R. MEDICOM, INC. | NON-STERILE SURGICAL MASK | 09/20/2005 |
| K123115 | ACME FILTER MASK INC. | ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P | 05/20/2013 |
| K230383 | ALG Health LLC | Savvy Surgical Mask - Level 3 | 03/06/2023 |
| K202128 | Allmed Medical Products Co., LTD | Allmed Surgical Face Masks (Ear loops) | 06/03/2021 |
| K202409 | Allmed Medical Products Co., Ltd. | Surgical Mask | 03/09/2021 |
| K202411 | Allmed Medical Products Co., Ltd. | Surgical Mask | 03/10/2021 |
| K212926 | Allure Gift Wraps Private Limited | AllureTM Surgical Mask | 09/16/2022 |
| K211249 | Altor Safety LLC | Altor Safety 3-Ply Surgical Mask (Model:62222) | 07/23/2021 |
| K211762 | Altor Safety LLC | Altor Safety 4-Ply Surgical Mask (Model:62232) | 09/03/2021 |
| K223270 | America's Supply Chains | POSEÖ Health Care Surgical Mask | 11/01/2022 |
| K222749 | AmericaÆs Supply Chains | High Fluid-Resistant Surgical and Procedure Mask | 11/14/2022 |
| K964358 | AMERICAN SEAL CO. | AMSEAL SURGICAL FACE MASK | 02/14/1997 |
| K211440 | American Surgical Mask Company LLC | ASM-301 Level 3 Surgical Mask | 06/02/2021 |
| K955557 | AMERICAN THRESHOLD HEALTHCARE | FLUID REISISTANT EYESHIELD MASK | 04/25/1996 |
| K955556 | AMERICAN THRESHOLD HEALTHCARE | FLUID RESISTANT MASK | 04/25/1996 |
| K211062 | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd | Medical Face Mask | 06/08/2021 |
| K201545 | Amphastar Nanjing Pharmaceuticals, Inc. | Surgical Face Mask | 02/12/2021 |
| K201380 | Andon Health Co., Ltd. | Livocare Surgical Mask | 10/07/2020 |
| K110027 | ANGELINE GROUP LTD. | SURGICAL FACE MASK; SURGICAL FACE MASK | 08/05/2011 |
| K211696 | Anhui Cleanpro Pharmpack Co., Ltd. | Disposable Surgical Face Mask | 11/30/2021 |
| K210302 | Anhui JBH Medical Apparatus Co., Ltd. | Disposable Medical mask | 05/14/2021 |
| K203801 | Anhui Jiabao Protective Equipments Co., Ltd | Disposable Surgical Face Mask | 04/06/2021 |
| K212368 | Anhui Tiankang Medical Technology Co., Ltd. | Surgical Face Mask | 10/24/2021 |
| K222809 | Anqing Mayfield Medical Limited | Medical Disposable Face Masks | 01/03/2023 |
| K211956 | AOK Tooling Limited | 039 Surgical Face Mask | 11/23/2021 |
| K220876 | AOK Tooling Limited | AOK 95A Medical Mask (20200049) | 07/27/2022 |
| K201517 | AOK Tooling Limited | Plain Surgical Mask | 09/04/2020 |
| K210101 | Armbrust Inc. | American-Made Surgical Mask | 01/26/2022 |
| K213347 | Asia Dynamics Inc., d/b/a ADI Medical | ADI Medical Surgical Face Mask | 01/25/2022 |
| K133070 | B.H. MEDICAL PRODUCTS CO., LTD. | SURGICAL FACE MASK (Ear Loops and Tie-on) | 06/22/2015 |
| K202843 | B.J.ZH.F.Panther Medical Equipment Co., Ltd | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | 01/12/2021 |
| K203524 | Bain Medical Equipment (Guangzhou) Co., Ltd. | Surgical Masks | 02/25/2021 |
| K211097 | Banyan USA LLC | Banyan USA Surgical Mask Level 3 | 09/22/2021 |
| K202069 | Base4 Group, Inc. | BASE4 Disposable Medical Mask | 12/01/2020 |
| K212302 | Baylab USA, LLC | BAYLAB 3-Ply Surgical Mask (BEACON I) | 12/07/2021 |
| K203425 | BDC Dental Corporation Ltd. | Surgical Mask | 03/05/2021 |
| K202029 | Beijing Biosis Healing Biological Technology Co., Ltd | Medical Surgical Mask | 12/16/2020 |
| K962286 | BERKLEY MEDICAL RESOURCES, INC. | 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD | 10/07/1996 |
| K971744 | BERKLEY MEDICAL RESOURCES, INC. | FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) | 07/28/1997 |
| K210815 | Biobase Scientific (Shandong) Co., Ltd. | Disposable Face Mask | 05/13/2021 |
| K202824 | Blackbriar Regulatory Services, LLC | BRS Procedure Face Mask | 03/25/2021 |
| K200923 | BYD Precision Manufacturer Co.Ltd. | Single-use Surgical Mask | 08/26/2020 |
| K210970 | BYD Precison Manufacturer Co., Ltd. | Single-Use Surgical Mask Model FE2311B | 07/21/2021 |
| K201871 | C & S Paper Yunfu Co., Ltd. | Surgical Mask | 08/12/2020 |
| K230569 | Cardinal Health | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | 07/03/2023 |
| K192374 | Cardinal Health 200, LLC | Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip | 12/02/2019 |
| K142990 | Cardinal Health 200, LLC | Insta-Gard Surgical and Procedure Face Mask | 03/04/2015 |
| K140155 | CARDINAL HEALTH 200, LLC | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | 06/20/2014 |
| K962654 | CARL PARKER ASSOCIATES, INC. | COMPLEAT SURGICAL MASK | 01/27/1997 |
| K971130 | CARL PARKER ASSOCIATES, INC. | DEFEND FLUID RESISTANT PLEATED MASK | 06/27/1997 |
| K202615 | Changzhou Combat Protective Equipment Co., Ltd. | Nordiwell Medical Face Mask | 12/31/2020 |
| K210181 | Changzhou Combat Protective Equipment Co., Ltd. | Nordiwell Surgical Face Mask | 03/09/2021 |
| K210445 | Changzhou Combat Protective Equipment Co., Ltd. | Nordiwell Surprotect Face Mask | 06/29/2021 |
| K211042 | Changzhou DSB Medical Co., LTD | Disposable Procedural Ear-loop Face Mask | 07/15/2021 |
| K210524 | Changzhou Holymed Products Co., Ltd. | Surgical Mask | 07/07/2021 |
| K203152 | Chaozhou Cecilia Technology Co., Ltd. | Disposable Face Mask | 08/11/2021 |
| K050689 | CHINA SURGICAL DRESSINGS CENTER CO.,LTD | SURGICAL FACE MASK | 10/26/2005 |
| K202457 | CHISON Medical Technologies Co., Ltd. | M1 Surgical Face Mask | 04/29/2021 |
| K202714 | Chongqing Chaoke Industry Development Co., Ltd. | Medical Face Mask | 06/11/2021 |
| K202759 | Chongqing COE Display Technology Co., Ltd. | Disposable medical surgical mask | 04/21/2021 |
| K210744 | Chongqing Pa Xijia Biotechnology Co., Ltd. | Surgical Mask | 12/14/2021 |
| K210856 | Chuzhou Daddy's Choice Science and Technology Co., Ltd. | Purism Disposable Surgical Mask | 07/28/2021 |
| K200576 | ClearMask, LLC | ClearMask Transparent Surgical Face Mask | 04/06/2020 |
| K203591 | Conod Medical Co., Limited | Single-use Medical Face Mask | 07/02/2021 |
| K213136 | Control Print Limited | CPL Surgical Face Mask | 12/24/2021 |
| K021539 | CREATIVE CONTRACT (M) SDN BHD | DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS | 03/05/2003 |
| K021546 | CREATIVE CONTRACT (M) SDN BHD | DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR | 03/05/2003 |
| K021533 | CREATIVE CONTRACT (M) SDN BHD | DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) | 03/05/2003 |
| K212273 | Cross Protection (M) Sdn Bhd | Cross Protection ResQ300 Plus Surgical Face Mask | 08/17/2022 |
| K082258 | CROSSTEX INTERNATIONAL | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | 10/16/2008 |
| K111343 | CROSSTEX INTERNATIONAL, INC. | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS | 10/06/2011 |
| K103303 | CROSSTEX INTERNATIONAL, INC. | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE | 12/23/2010 |
| K012602 | CROSSTEX INTL. | CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX | 01/22/2002 |
| K203534 | Crown Name Disposable Hygiene Products Fty., Ltd. | Surgical face mask (Model: Flat Ear Loop/CN102) | 07/21/2021 |
| K203012 | Customfab, INC. | Surgical Mask | 04/11/2021 |
| K972849 | CYPRESS MEDICAL PRODUCTS, LTD. | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | 05/28/1998 |
| K972883 | CYPRESS MEDICAL PRODUCTS, LTD. | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | 02/26/1998 |
| K213970 | Danameco Medical Joint Stock Corporation | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply | 01/23/2022 |
| K210705 | Defender Safety Inc. | Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 | 05/06/2021 |
| K211772 | Defender Safety Inc. | PMW01 Procedure Mask Level 1 | 12/06/2021 |
| K201479 | DemeTECH Corporation | DemeMASK | 07/24/2020 |
| K964114 | DEPUY, INC. | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS | 05/06/1997 |
| K210018 | Diasia Biomedical Technology Co., Ltd. | Disposable Medical Mask | 04/11/2021 |
| K203174 | Dong Guan Kinyet Metal Products Co., Ltd | Disposable Medical Mask | 08/02/2021 |
| K220067 | Dongguan Missadola Technology Co., Ltd | Medical Surgery Mask, Model:2626-7 | 08/30/2022 |
| K202655 | Dongguan Runlin Medical Supplies Technology Co., LTD | Disposable Medical Mask | 04/05/2021 |
| K210372 | Dongguan Shin Yi Healthcare Products Factory | Disposable Surgical Mask | 06/07/2021 |
| K061864 | DUKAL CORP. | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | 09/15/2006 |
| K070407 | DUKAL CORP. | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | 03/26/2007 |
| K201421 | Dukal Corporation | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons | 02/05/2021 |
| K201732 | Dukal Corporation | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On | 02/16/2021 |
| K230395 | DURIO PPE SDN BHD | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | 07/17/2023 |
| K213894 | DWFritz Automation, Inc. | DWFritz ASM2000 | 03/14/2022 |
| K202096 | EcoGuard Inc. | 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On | 02/02/2021 |
| K223823 | Efofex, Inc. | Disposable Surgical Face Mask | 03/27/2023 |
| K970440 | EKONIC COMPANY, LTD. | EKONIC DENTAL/MEDICAL MASK (MD 610) | 03/27/1997 |
| K222551 | Entreprise Premont Inc. | Humask Pro Vision, Humask Pro Vision 3000 | 11/10/2022 |
| K093901 | EPARD PROTECTIVE PRODUCTS, LTD | SURGICAL FACE MASK | 09/10/2010 |
| K210761 | Esstee Exports Health Care Division | Velguard Surgical Face Mask | 07/16/2021 |
| K203388 | Everwin Toys (Dongguan)., Ltd. | Disposable medical mask | 06/04/2021 |
| K212111 | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi | Myflon Surgical Mask Level 3 | 01/23/2022 |
| K210225 | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd | Surgical Face Mask | 03/04/2021 |
| K220512 | Fomed Industries Inc. | Disposable Surgical Face Mask (M01, M02) | 04/25/2022 |
| K212610 | Foshan Nanhai Plus Medical CO LTD | Surgical Face Mask | 01/26/2022 |
| K202424 | Foshan Xinbao Technology Co., Ltd. | Surgical Mask-Models CR02-2, CR02 | 03/31/2021 |
| K210063 | Freudenberg Performance Materials LP | Freudenberg Surgical Mask | 02/05/2021 |
| K202214 | FSSC, LLC | IFM Surgical Mask Model SM3 | 03/02/2021 |
| K203455 | Fujian Kang Chen Daily Necessities CO., LTD | Disposable Medical Mask | 09/13/2021 |
| K210870 | Fujian MEO Medical Technology Limited | MEO Med Disposable Medical Face Mask | 07/30/2021 |
| K202331 | Gemtier Medical (Shanghai) Inc | Medical Face Mask | 02/02/2021 |
| K202493 | Gemtier Medical (Shanghai) Inc | Medical Face Mask | 02/04/2021 |
| K953754 | GLOBAL HEALTHCARE, INC. | GLOBAL HEALTHCARE FACE MASK | 01/26/1996 |
| K210860 | GRI-Alleset, Inc | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | 04/07/2022 |
| K202387 | Guangdong Bida Medical Technology Co., Ltd. | Disposable Surgical Face Mask | 04/23/2021 |
| K223068 | Guangdong Golden Leaves Technology Development Co., LTD | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) | 11/23/2022 |
| K202761 | Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. | Medical Surgical Mask (Non-sterile) | 04/11/2021 |
| K203200 | Guangdong Haiou Medical Apparatus Co., Ltd. | Disposable Medical Surgical Face Mask | 06/16/2021 |
| K201974 | Guangdong Horigen Mother & Baby Products Co., Ltd | Single-use medical face mask | 03/07/2021 |
| K220187 | Guangdong Jia Mei Biological technology Co.Ltd | Medical Surgical Mask (Model: JM92, JM92B) | 03/25/2022 |
| K202211 | Guangdong Kaidi Garments Co.,Ltd | Disposable Medical Surgical Face Masks | 12/22/2020 |
| K213450 | Guangdong Kingfa Sci.&Tech. Co., Ltd. | Medical surgical mask (Black mask, Level 1 and Level 3) | 04/05/2022 |
| K202107 | Guangdong Kingfa Sci.&Tech.Co., Ltd. | Medical Protective Mask | 01/15/2021 |
| K202139 | Guangdong Kingfa SCI.&Tech.Co., Ltd. | Medical surgical mask | 11/20/2020 |
| K201622 | Guangdong KINGFA Sci.&Tech.Co.,Ltd. | Medical surgical mask | 11/24/2020 |
| K210222 | Guangdong Lide Medical Technology Co., Ltd. | Disposable Medical Mask | 11/02/2021 |
| K210023 | Guangdong Winsun Personal Care Products Co.,Ltd | Surgical Face Mask | 04/02/2021 |
| K212997 | Guangdong Zhizhen Biological Medical Co., Ltd | Surgical Mask | 01/14/2022 |
| K202650 | Guangdong Zhong Ling Industrial Group Co., Ltd. | Medical disposable face mask non sterile | 03/24/2021 |
| K222545 | Guangzhou Fuzelong Hygiene Material Co., Ltd | Disposable Medical Mask | 05/19/2023 |
| K203646 | Guangzhou Mei Yi Kang Medical Technology CO., LTD. | Disposable Medical Face Mask | 04/22/2021 |
| K212994 | Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. | Medical Face Mask | 01/17/2022 |
| K222204 | Guangzhou ZhengKang Medical Equipment Co.,Ltd | Medical Surgical Mask | 09/23/2022 |
| K212460 | Guangzhou ZhengKang Medical Equipment Co.,Ltd | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm╫9.5cm)) | 11/05/2021 |
| K202627 | Guilin HBM Sanitary Protections, Inc | Medical Face Masks | 02/03/2021 |
| K093179 | H&H RESEARCH COMPANY | MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) | 07/14/2010 |
| K212471 | Haian Medigauze Co., Ltd | Medical Face Mask | 11/04/2021 |
| K143287 | Halyard Health, Inc. | Fluidshield* Surgical Mask with Expanded Chamber | 03/24/2015 |
| K202316 | Han Zhaoqing Sporting Goods Company Limited | Medical mask (Model: KKF-1A) | 03/03/2021 |
| K202314 | Han Zhaoqing Sporting Goods Company Limited | Procedure face mask (Model: KKF-2A) | 01/13/2021 |
| K201698 | Hangzhou Mycode Bio-Medicine Co., Ltd. | Medical Surgical Mask | 03/15/2021 |
| K202133 | Hangzhou Qianzhiya Sanitary Products Co., Ltd | Disposable Medical Mask | 03/25/2021 |
| K213736 | Hangzhou Runheng Medical Co., Ltd. | Medical Face Mask | 03/31/2022 |
| K221038 | Hantech Medical Device Co., Ltd. | Disposable Medical Masks | 09/01/2022 |
| K212366 | Heartland Health Products | Heartland Health Surgical Mask | 02/19/2022 |
| K212097 | Hebei Titans Hongsen Medical Technology Co., LTD | Disposable medical surgical mask | 08/18/2021 |
| K212944 | Heilongjiang Yinjia Medical Equipment Co., Ltd. | Disposable Surgical Mask | 12/15/2021 |
| K230617 | Henan Chaoya Medical Equipment Co., Ltd. | Surgical Face Mask (L 175*95mm) | 06/01/2023 |
| K202842 | Henan Huibo Medical Co.,Ltd. | Medical surgical mask | 11/26/2021 |
| K212330 | HeNan YADU Industrial Co., Ltd. | Yadu Medical Face Mask (Level 1) | 03/14/2022 |
| K201095 | HomTex, Inc. | Sovereign America Surgical Face Mask | 03/19/2021 |
| K211066 | Homtex, Inc. | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 | 08/19/2021 |
| K211497 | Honeywell Safety Products | Surgical Mask | 07/28/2021 |
| K043199 | HONG YA NON-WOVEN PRODUCTS CO., LTD. | SURGICAL FACE MASK | 02/16/2005 |
| K060776 | HONG YA NON-WOVEN PRODUCTS CO., LTD. | SURGICAL FACE MASK | 05/25/2006 |
| K212575 | Hubei Huanfu Plastic Products Co., Ltd | Surgical Face Mask | 11/14/2021 |
| K212726 | Hubei Huaqiang High-Tech Co., Ltd. | Disposable Medical Surgical Mask | 03/23/2022 |
| K211363 | HuBei Kangning Protective Products Co., Ltd. | Medical Face Mask | 07/24/2021 |
| K212398 | Hubei Kimsoul Industrial Co., Ltd | Surgical Face Mask (Non-sterile) | 12/15/2021 |
| K220487 | Hubei Mediunion Medical Products Co., Ltd. | Disposable Medical Face Mask | 04/26/2022 |
| K223003 | Hubei Medlink Healthcare Co., Ltd | Banded Face Mask | 11/18/2022 |
| K214087 | Hubei Medlink Healthcare Co., Ltd | Medical Face Mask | 03/08/2022 |
| K220777 | Hubei Qianjiang Kingphar Medical Material Co., Ltd | Surgical face mask | 07/19/2022 |
| K214085 | Hubei Wanli Protective Products Co. Ltd | Disposable Medical Mask | 04/06/2022 |
| K210150 | Hubei Wanli Protective Products Co., Ltd. | Disposable Medical mask | 06/02/2021 |
| K222483 | Hubei Woozon Healthcare Co.,Ltd. | Surgical Face Mask | 01/04/2023 |
| K212120 | Hubei Xinxin Non-woven Co.,Ltd. | Surgical Masks | 01/28/2022 |
| K211899 | Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD | Surgical Face Mask | 10/04/2021 |
| K201852 | Huizhou Foryou Medical Devices Co., Ltd | Surgical Mask-Model Number: Ear Loop, Flat-Pleated | 03/02/2021 |
| K211165 | Huizhou Jie Bai Purification Co.,Ltd. | Medical Face Masks, Model Name:MY020003 | 11/09/2021 |
| K203078 | HuiZhou TianChang Industrial Co., Ltd | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW | 08/19/2022 |
| K220824 | Hunan Chopard Medical Devices Co., Ltd | Medical Surgical Mask (Planar type) | 05/19/2022 |
| K202161 | Hunan EEXI Technology & Service Co., Ltd. | Surgical Face Mask | 03/10/2021 |
| K202439 | Hunan EEXI Technology & Service Co.,Ltd. | Disposable Medical Face Mask | 03/08/2021 |
| K202358 | Hunan Heng Chang Pharmaceutical Co., Ltd. | Protective Face Mask for Medical Use | 01/29/2021 |
| K202354 | Hunan Heng Chang Pharmaceutical Co., Ltd. | Surgical Mask-Model Number CW01 | 09/08/2020 |
| K210767 | Hunan Triplex Precision Medical Devices Co., Ltd | Surgical Masks, Model:FE-1 | 06/10/2021 |
| K210487 | Hunan Yuankang Biological Technology Co., Ltd | MIPLNI YK-244 Disposable Surgical Mask | 03/16/2021 |
| K213724 | Hunan Zhenheyikang Medical Instrument Co., Ltd | Medical Surgical Mask | 02/20/2022 |
| K212046 | Impertech Industries Ltd. | Impertech Surgical Face Mask | 11/18/2021 |
| K202511 | Improve Medical (HuNan) Co., Ltd. | Disposable Medical Surgical Mask | 02/02/2021 |
| K203565 | Inno Lifecare | Surgical 3D Mask | 10/19/2021 |
| K961402 | INNOVATIVE OUTSOURCING SOLUTIONS | STS SHIELD WITH MASK | 07/12/1996 |
| K210422 | INTAI Technology Corp. | INTAI Surgical Mask (non-sterile) | 03/30/2022 |
| K202708 | Intco Medical(HK) Co., Ltd. | Surgical Face Masks | 03/30/2021 |
| K100846 | INTERNATIONAL MEDSURG CONNECTION | IMC SURGICAL FACE MASK | 08/16/2010 |
| K201896 | IOB Medical Inc | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | 03/30/2021 |
| K230380 | Iris USA | Surgical Face Masks, Model: EFMDS-L50Pn BLU | 08/03/2023 |
| K211425 | J.K. Private Stock Inc. | Private Stock Labs Surgical Face Mask | 10/04/2021 |
| K202794 | Jiande Chaomei Daily Chemicals Co., Ltd | Surgical face mask: F-Y1-A | 12/13/2021 |
| K212293 | Jiangmen Ningrui Medical Supplies Co., Ltd. | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) | 10/25/2021 |
| K202577 | Jiangmen Sure&Me Medical Product CO., LTD | Medical Surgical Mask-Model MP002-5, MP002-6 | 01/11/2021 |
| K202905 | Jiangsu Excellence Medical Supplies Co., Ltd | Disposable Face Mask | 03/26/2021 |
| K201718 | Jiangsu Guangda Medical Material Group Co., Ltd. | GD Disposable Medical Face Mask | 04/15/2021 |
| K201754 | Jiangsu JianYu Health Medical Co., Ltd. | JianYu Surgical Mask | 12/30/2020 |
| K202605 | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. | Standard Procedure Mask, Standard Surgical Mask | 02/10/2021 |
| K202640 | Jiangsu Medpure Biological Technology Co., Ltd. | Surgical Mask | 01/22/2021 |
| K202205 | Jiangsu Micsafe Medical Technology Co., Ltd | Surgical Face Mask | 03/09/2021 |
| K212826 | Jiangsu Nanfang Medical Co., Ltd. | Disposable Medical Mask | 01/19/2022 |
| K202491 | Jiangsu NewValue Medical Products Co., Ltd. | Disposable Surgical Face Mask | 01/06/2021 |
| K202061 | Jiangsu Province Jianerkang Medical Dressing Co., Ltd | Medical Face mask | 12/23/2020 |
| K211454 | Jiangsu Xingtong Biotechnology Group Co., Ltd. | Surgical mask | 08/18/2021 |
| K202277 | Jiangxi 3L Medical Products Group Co., Ltd | Surgical Face Mask | 09/25/2020 |
| K212375 | Jiangxi Bestgrand Health Technology Co., Ltd. | Disposable Medical Surgical Mask | 01/04/2022 |
| K202904 | Jiangxi Feilikang Medical Technology Co., Ltd. | Surgical Face Mask | 01/21/2021 |
| K212913 | Jiangxi Ganlong Pharmaceutical Co.,Ltd. | Surgical Face Mask | 01/14/2022 |
| K210429 | Jiangxi Heying Pharmaceutical Co., Ltd | Disposable Surgical Face Mask | 06/02/2021 |
| K210622 | Jiangxi Hongda Medical Equipment Group Co., Ltd. | Single-Use Medical Face Mask | 10/08/2021 |
| K221173 | Jiangxi SanHao Medical Instruments Co.,Ltd | Surgical Mask (Model: 0868F, 0866F) | 07/06/2022 |
| K202719 | Jiangxi Sanxin Medtec Co., Ltd. | Disposable Medical Face Masks | 01/04/2021 |
| K210845 | Jiaxing Amazing Travel-Ware CO.,LTD | Disposable Surgical Mask (Model: YYKZ-01) | 10/12/2021 |
| K210304 | Jin Pin Electrical CO., LTD. Zhuhai S.E.Z. | Surgical Mask | 05/04/2021 |
| K123787 | JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L | GREENCROSS SURGICAL MASK | 07/17/2013 |
| K222266 | Jingzhou Haixin Green Cross Medical Products Co.,Ltd. | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | 09/26/2022 |
| K210007 | Jinhua Jingdi Medical Supplies Co., Ltd | Face Mask | 04/23/2021 |
| K220191 | Jiujiang Taixin Technology Co., Ltd. | Disposable Face Mask | 05/24/2022 |
| K201470 | JKH USA, LLC | Disposable Medical Face Mask | 09/08/2020 |
| K221682 | JSN Holdings, LLC | Ideal Med Pro 3-Ply Disposable Face Mask | 01/13/2023 |
| K203704 | Juntech(Jiaxing)Healthcare Materials Co,.Ltd | Surgical face mask | 06/04/2021 |
| K220637 | KDI Med Supply | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask | 03/25/2022 |
| K202899 | Kenpax International Limited | Procedure Mask, Surgical Mask | 05/20/2021 |
| K111402 | KIMBERLY-CLARK | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | 10/20/2011 |
| K131879 | KIMBERLY-CLARK CORP. | KC 300 SURGICAL MASK | 12/20/2013 |
| K110455 | KIMBERLY-CLARK CORP. | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS | 04/29/2011 |
| K232359 | Kingstar Medical (Xianning) Co., Ltd. | Surgical face mask | 10/02/2023 |
| K203528 | KNH Surgical Face Mask | KNH Surgical Face Mask | 11/16/2022 |
| K201844 | Lear Corporation | Surgical Face Mask, Surgical Mask | 07/14/2021 |
| K952961 | LHB INDUSTRIES, INC. | BODY FLUID BARRIER KIT | 01/23/1996 |
| K202240 | LHM Medical Technology (Hong Kong) Limited | Disposable Surgical Mask/Fluid Resistant Procedure Mask | 02/25/2021 |
| K211260 | Liaoning Shengjingtang Biotechnology Co., Ltd. | Sheng Jing Tang Surgical Mask | 01/10/2022 |
| K211378 | Liberty Mask LLC | LM Surgical Mask Level 3, LM Surgical Mask Level 2, | 12/16/2021 |
| K220377 | Little Rapids Corporation | Procedure Mask | 06/24/2022 |
| K211751 | Lonestar Meadows LLC | WELLTRUST WT-III Mask with Flat Earloop | 09/17/2021 |
| K203756 | Lucky Textile Industrial(Wuxi) Co.,Ltd. | Disposable Surgical Mask | 06/10/2021 |
| K222335 | Luoyang Sunmed Devices Co., Ltd. | Surgical Mask | 10/11/2022 |
| K212649 | Lyncmed Medical Technology (Beijing) Co., Ltd. | Disposable Surgical Face Mask | 10/25/2022 |
| K211631 | Macheng Thimble Technology Investment Co., Ltd | Surgical Face Mask | 08/18/2021 |
| K211487 | MAF Clothing Pvt Ltd Unit-3 | MAF Guard | 12/08/2021 |
| K220670 | Magnum Health And Safety Pvt Ltd | Magnum | 06/28/2022 |
| K220550 | MAKRITE INDUSTRIES, INC. | Disposable Surgical Face Mask (M663BE, M663BT) | 06/14/2022 |
| K034015 | MEDIPACK MEDICAL PACKAGING MFG. CO. | EARLOOP PROCEDURE MASK | 02/20/2004 |
| K965107 | MEDLINE INDUSTRIES, INC. | MEDLINE ADMISSION KITS | 03/11/1997 |
| K991559 | MEDLINE INDUSTRIES, INC. | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD | 08/23/1999 |
| K223236 | Medline Industries, LP | Medline Surgical Face Mask and Medline Procedural Face Mask | 03/24/2023 |
| K041047 | MEDSPRING GROUP, INCORPORATED | ULTRADENT CARBON MASK - UPI #342 | 12/01/2004 |
| K203376 | Medtecs (Taiwan) Corp. | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G | 03/02/2022 |
| K213617 | Megasoft (China) Co., Ltd. | Surgical Face Mask | 02/11/2022 |
| K030239 | MEGATECH SCIENTIFIC PTE LTD | MEGATECH SCIENTIFIC FACE MASK | 07/24/2003 |
| K200847 | Mexpo International Inc. | Surgical Face Mask | 04/23/2020 |
| K211984 | Mid-America Safety Corp. | MASC Surgical Mask | 07/25/2021 |
| K965043 | MINNESOTA MINING AND MFG. CO. | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE | 03/10/1997 |
| K992604 | MITSUI TEXTILE CORP. | HENRY SCHEIN SURGICAL MASK | 01/28/2000 |
| K201549 | Modern Healthcare Corp. | Motex Anti-Fog Surgical Face Mask | 08/26/2020 |
| K063043 | MODERN HEALTHCARE CORP. | SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP | 03/21/2007 |
| K212867 | Nanchang Kanghua Health Materials Co., Ltd | Medical Surgical Mask | 12/11/2021 |
| K211295 | Nanjing 3H Medical Products Co., Ltd. | Surgical Mask (sterile) | 11/24/2021 |
| K212264 | Nantong Taiweishi Medical Technology Co., Ltd. | Surgical Face mask | 11/13/2021 |
| K203426 | Nantong Taiweishi Medical Technology Co., Ltd. | Surgical Face Mask (non-sterile) | 02/18/2021 |
| K211750 | National Bridge Industrial (S.Z.) Co., Ltd. | Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) | 12/20/2021 |
| K201853 | Naton Biotechnology (Beijing) Co., Ltd. | Naton Disposable Surgical Face Mask | 04/23/2021 |
| K202647 | Ningbo Green Textile Co., Ltd. | Surgical Mask | 04/26/2021 |
| K202745 | Ningbo Jingeao Electronics Inc. | Disposable medical face mask | 08/23/2021 |
| K202746 | Ningbo Jingeao Electronics Inc. | Surgical mask | 08/27/2021 |
| K203418 | Ningbo Ouhan Medical Device Co., Ltd. | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) | 09/17/2021 |
| K210256 | Ningbo Shun Ye Medical Company, Ltd. | CiRx (R) Surgical Mask | 08/19/2021 |
| K203265 | NP Medical Inc | nPro Surgical Mask | 02/09/2021 |
| K231618 | Original Mattress Factory Inc. | 3 Layer Surgical Mask (134252531) | 07/28/2023 |
| K201182 | Pac-Dent, Inc. | iMask Disposable Surgical Face Mask | 02/19/2021 |
| K221209 | PADM Medical Inc. | PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops | 03/08/2023 |
| K221409 | Paneffort, LLC | Paneffort 3-ply Surgical and Procedural Masks | 07/25/2022 |
| K141875 | PASTURE PHARMA PTE LTD | Pasture 60S Surgical Mask | 05/05/2015 |
| K201137 | PFM Medical, Inc | Asept Surgical Face Mask | 08/19/2020 |
| K222426 | Phu Bao Group Company Limited | Perfetta Moderate Medical Face Mask | 09/02/2022 |
| K203064 | Plastikon Industries | ICU Health Surgical Mask | 03/23/2021 |
| K220520 | PM Excellence LLC | PM Excellence SEQUR 100 Surgical Face Mask | 12/15/2022 |
| K220944 | PointCore, Inc. | PointCore Surgical Mask | 09/09/2022 |
| K202595 | Premier Guard USA LLC | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | 01/21/2021 |
| K211275 | PremiumEStore, LLC | AirMax Procedure Mask | 05/25/2021 |
| K211520 | PremiumEStore, LLC | Amerishield Surgical Mask | 06/15/2021 |
| K061716 | Prestige Ameritech | PRESTIGE AMERITECH FACE MASK | 08/14/2006 |
| K171162 | Prestige Ameritech | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | 08/15/2017 |
| K152561 | Prestige Ameritech, Ltd | Communicator Surgical Facemask with Clear Window | 06/03/2016 |
| K081633 | PRIMED MEDICAL PRODUCTS INC. | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | 08/11/2008 |
| K092012 | PRIMED MEDICAL PRODUCTS INC. | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 | 09/25/2009 |
| K021076 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM | 04/16/2002 |
| K001951 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | 09/08/2000 |
| K011789 | PRIMELINE MEDICAL PRODUCTS, INC. | PROCEDURE MASKS: PM4-301 AND PM4-304 | 06/22/2001 |
| K153409 | PROTECT U GUARD, LLC | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | 11/15/2016 |
| K212740 | Puravita M, LLC | Puravita Medical Fold Flat Surgical Mask | 12/02/2021 |
| K220597 | Qingdao Bestex Rubber & Plastic Products Co.,Ltd. | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | 05/26/2022 |
| K210218 | Qingdao Hainuo Biological Engineering Co., Ltd. | SURGICAL MASK, Model Name:C015 | 05/07/2021 |
| K202580 | Qingdao Likangyuan Medical Device Co., Ltd. | Disposable Surgical Mask | 06/07/2021 |
| K202628 | Qinghai Zhong Dao Win-win Medical Protective Equipment Co., | Disposable Medical Face Mask | 03/19/2021 |
| K211451 | Qinhuangdao Taizhi Medical Technology Co., Ltd. | Disposable Surgical Mask (non sterile) | 08/25/2021 |
| K223686 | Qinhuangdao Taizhi Medical Technology Co., Ltd. | Medical Protective Masks | 02/07/2023 |
| K212205 | Qinhuangdao Taizhi Medical Technology Co., Ltd. | Medical Protective Masks | 10/14/2021 |
| K201924 | Qiqihar Hengxin Medical Supplies, Ltd. | Single-Use Surgical Mask | 03/15/2021 |
| K201691 | Qiqihar Hengxin Medical Supplies, Ltd. | Single-Use Surgical Mask With Ear Loop | 09/17/2020 |
| K214035 | R&R Medical Corporation Ltd | LAITEST Medical Face Mask | 09/13/2022 |
| K964722 | RACAL FILTER TECHNOLOGIES, INC. | DELTA N95 RESPIRATOR | 02/07/1997 |
| K964723 | RACAL FILTER TECHNOLOGIES, INC. | RACAL N95 RESIRATOR | 02/07/1997 |
| K211105 | Ray Co., Ltd. | Ear-Friendly Mask | 05/17/2021 |
| K212451 | ReMade USA LLC | Surgical Mask | 09/10/2021 |
| K203190 | RFX+CARE Manufactoring Co., Ltd. | Surgical Face Mask | 06/02/2021 |
| K202903 | Rizhao Sanqi Medical & Health Articles Co., Ltd. | Surgical Face Mask | 03/24/2022 |
| K214094 | ROKI Co., Ltd. | ROKI Surgical Mask | 02/24/2022 |
| K221134 | SafeSource Direct, LLC | Procedure Mask with Ear Loops and Surgical Mask with Ties | 05/19/2022 |
| K960048 | SAFETEC OF AMERICA, INC. | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS | 07/12/1996 |
| K042654 | SAFETY-MED PRODUCTS, INC. | PROTECTION PLUS EARLOOP PROCEDURE MASK | 12/17/2004 |
| K210840 | Safeway Industry Healthcare. | Disposable Surgical Mask | 06/22/2021 |
| K964168 | SAGE PRODUCTS, INC. | PROCEDURE SPECIFIC KITS | 03/03/1997 |
| K210015 | Sample King Manufacturing Ltd | Surgical Face Mask | 06/10/2021 |
| K160269 | SAN-M PACKAGE CO., LTD. | Surgical Face Masks (Ear loops and Tie-on) | 09/06/2016 |
| K221534 | San-M Package Co., Ltd. | Surgical Face Masks (Ear Loops And Tie-On) | 09/16/2022 |
| K221957 | Savewo Limited | Savewo ClassicMASK | 09/02/2022 |
| K203101 | Secured Ortho Manufacturing of America, LLC | Secure Wear USA Surgical Face Mask | 03/31/2021 |
| K220302 | Shandong Aida Medical Products Co., Ltd | Disposable surgical face mask | 11/16/2022 |
| K210518 | Shandong Haidike Medical Products Co., Ltd. | Surgical Face Mask | 06/14/2021 |
| K203380 | Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. | Disposable Surgical Face Mask | 01/06/2023 |
| K201629 | Shandong Shengquan New Material Co., Ltd. | Medical Face Mask | 12/14/2020 |
| K201537 | Shandong Shengquan New Material Co., Ltd. | Protective Face Mask for Medical Use | 09/04/2020 |
| K211552 | Shandong Shengquan New Materials Co., Ltd. | Surgical mask | 08/11/2021 |
| K202594 | Shandong T&F Nonwoven Co., LTD | Medical Surgical Masks-Non Sterile | 01/06/2021 |
| K221272 | Shandong Xingyu Gloves Co., Ltd. | Medical Face Mask | 06/28/2022 |
| K210409 | Shandong Zhushi Pharmaceutical Group Co., Ltd | Disposable Surgical Face Mask | 07/28/2021 |
| K210643 | Shandong Zhushi Pharmaceutical Group Co., Ltd | Disposable Surgical Face Mask | 08/04/2021 |
| K221838 | Shanghai Hua En Industrial CO LTD | Surgical Face Mask (HNFM0103) | 08/17/2022 |
| K221222 | Shanghai Hua En Industrial CO LTD | Surgical Face Mask (HNFM0304) | 06/06/2022 |
| K202341 | Shanghai Jianzhong Medical Packaging Co., Ltd. | Disposable Surgical Mask | 02/12/2021 |
| K201601 | Shanghai Kindly Medical Instruments Co., Ltd. | Medical Face Mask | 11/10/2020 |
| K111559 | SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. | SURGICAL MASKS | 09/16/2011 |
| K211794 | Shanghai No.9 Knitting Mill Co., Ltd. | Disposable surgical mask | 09/28/2021 |
| K212235 | Shanghai Yunqing Industrial Co., Ltd. | Surgical Face Mask | 12/06/2021 |
| K210380 | Shantou T&K Medical Equipment Factory Co.,Ltd | Medical surgical mask | 07/08/2021 |
| K201991 | Shenzhen Everwin Precision Technology Co., Ltd. | Medical surgical mask | 11/23/2020 |
| K202513 | Shenzhen Jinko Industrial Co., Ltd | Disposable Medical Face Mask-Model FM-04 | 04/09/2021 |
| K211353 | Shenzhen Lyttop Healthcare Limited | Medical Face Mask | 08/11/2021 |
| K202126 | Shenzhen Peninsula Medical Co. Ltd | Disposable Surgical Mask | 06/08/2021 |
| K210878 | Shenzhen RealTone Medical Appliance Co., Ltd. | Surgical Face Mask (Model: CM2006, CM2008, A88) | 09/28/2021 |
| K213358 | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | Surgical Mask | 03/04/2022 |
| K990719 | SHUENN BAO SHING CORP. | EARLOOP FACE MASK | 07/12/1999 |
| K210813 | Sichuan Pharmaceutical. Inc. | Medical Surgical Mask | 10/08/2021 |
| K210908 | Sichuan Prius Biotechnology Co., Ltd. | Surgical Mask | 09/26/2021 |
| K152197 | Skypro Medical Supplies Company | Skypro, SP01 Mask | 08/26/2016 |
| K202255 | Skypro Medical Supplies Company | Skypro, SP02 Mask (3) | 12/24/2021 |
| K230093 | Social Medical Supply LLC | Disposable 4 Layers Surgical Face Mask | 03/02/2023 |
| K220378 | Sparta East, LLC | Sparta 3-Ply Surgical Disposable Face Mask | 06/30/2022 |
| K201624 | SpinTech LLC | Spin Care Disposable Protective Mask | 03/18/2021 |
| K212109 | SpinTech LLC | Spin Care Disposable Protective Mask Level 3 | 11/14/2021 |
| K203776 | SQ Medical Supplies Inc. | Surgical Masks, Model SNN200640 & MN112 | 03/25/2021 |
| K202607 | String King Lacrosse, LLC | Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs | 04/23/2021 |
| K211296 | Sunsmed Protective Products Ltd. | Surgical face mask | 09/11/2021 |
| K962443 | SURVIVAIR, INC. | N95 FILTERING FACEPIECE | 01/03/1997 |
| K210244 | Suzhou Bolisi Medical Technology Co., Ltd | Disposable Medical Face Mask | 07/12/2021 |
| K212526 | Suzhou JaneE Medical Technology Co., Ltd. | Surgical Face Mask | 11/09/2021 |
| K210042 | Suzhou Letian Protective Products Co., Ltd. | Disposable Surgical Mask | 11/17/2021 |
| K211861 | Taiji Medical Supplies, Inc. | TAIJI Professional Series Level 3 Surgical Face Mask | 07/28/2021 |
| K212863 | Taiwan Comfort Champ Manufacturing Co., Ltd. | Surgical Face Mask | 02/19/2022 |
| K211773 | Taiwan Seafood and Fish Corporation | Single-use Surgical Mask | 12/02/2021 |
| K212203 | Taizhou Donghaixiang Protective Equipment Co., Ltd | Dong Hai Xiang Surgical Mask | 04/07/2022 |
| K213406 | Texas MedPlast LLC | Savvy Mask - Level 3 Surgical Face Mask | 11/18/2021 |
| K203775 | The Aleen International Corporation | AIC disposable medical mask | 03/12/2021 |
| K211771 | The GOOD Corporation | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical | 08/24/2022 |
| K963568 | THE INNOVATIVE APPROACH, CORP. | MASK SURGICAL | 02/25/1997 |
| K211255 | Tianchang Kanghui Protective Products CO LTD | Surgical Mask | 08/28/2021 |
| K210030 | Tianjin Aoshang Outdoor Equipment Co., Ltd. | Medical Surgical Mask | 04/23/2021 |
| K201625 | Tianjin Saiyuan Technology CO., LTD | Disposable Medical Surgical Mask | 01/12/2021 |
| K202323 | Tianjin Teda Jinshan Easy Packing Manufacture Co., LTD | Disposable Medical Surgical Masks | 02/02/2021 |
| K100800 | TIDI PRODUCTS, LLC | TIDI FACEMASK | 06/14/2010 |
| K092580 | TIDI PRODUCTS,LLC | TIDI FACEMASK | 02/23/2010 |
| K122717 | TIGER MEDICAL PRODUCTS LTD | FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK | 12/21/2012 |
| K102713 | TIGER MEDICAL PRODUCTS LTD | TIGER FLAT SURGICAL MASK | 01/25/2011 |
| K984389 | TOP WHOLESOME ENTERPRISE CO., LTD. | TOP WHOLESOME FACE MASK | 04/09/1999 |
| K210102 | Topwide (Hubei) Medical Products Manufacturer | Topwide Surgical Face Mask | 12/17/2021 |
| K961217 | TRANSIDYNE GENERAL CORP. | BODILY FLUID DISPOSAL KIT | 07/25/1996 |
| K970835 | TUCKER & ASSOCIATES | FACE MASK, SURGICAL MASK, NON-STERILE | 09/03/1997 |
| K022256 | TUCKER & ASSOCIATES | SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN | 04/26/2004 |
| K210641 | Tuosheng Protective Products (Ningbo) Co., Ltd | Disposable Medical Mask | 06/07/2021 |
| K202137 | U-Play Products Corporation | Disposable medical mask | 03/04/2021 |
| K210147 | Unicoglobal, Inc. | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield | 12/22/2021 |
| K220749 | Unimax Medical Products Co., Ltd. | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP | 05/13/2022 |
| K202463 | Unisources Group LLC | Disposable Surgical Mask | 09/18/2020 |
| K955513 | UNITED MEDICAL ENT., INC. | SURGICAL MASK (NON-STERILE) | 04/22/1996 |
| K202697 | United Sewing Automation Inc. | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask | 05/13/2021 |
| K210513 | Universal Incorporation | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 | 09/29/2021 |
| K173062 | V&Q Manufacturing Corporation | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | 01/25/2018 |
| K040333 | VALUMAX INTL., INC. | VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS | 06/07/2004 |
| K210772 | VR Vertical LLC dba XRGO | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) | 09/22/2021 |
| K202710 | Wanxinda (Guangzhou) Technology Product Co., Ltd | Disposable Medical Face Mask | 03/09/2021 |
| K202548 | Wanxinda (Guangzhou) Technology Product Co., Ltd | Surgical Face Mask | 03/10/2021 |
| K223045 | Wealth Lead Industrial Limited | 3-Ply Disposable Medical Mask | 12/07/2022 |
| K210348 | Weihai Dishang Medical Technology Co., Ltd | Disposable Medical Surgical Mask | 10/24/2021 |
| K212807 | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Surgical Masks | 12/03/2021 |
| K222697 | Wellmed Dental Medical Supply Co., Ltd. | Disposable Medical Face Mask (DF3-001) | 11/04/2022 |
| K101000 | WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD | WELLMIEN SURGICAL MASK | 08/09/2010 |
| K201868 | Wellpower Sporting Goods Co., Ltd | Phyziofit Medical Surgical Mask | 02/22/2021 |
| K211536 | Welspun India Limited | Welspun Health Surgical Mask | 09/01/2021 |
| K212299 | Wepon Medical Technology Co., Ltd. | Medical Surgical Mask | 01/04/2022 |
| K141085 | WESTTEC, LLC | WestTec Procedure Facemask;WestTec Surgical Facemask | 03/27/2015 |
| K001997 | WHITE KNIGHT HEALTHCARE, INC. | WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) | 04/02/2001 |
| K001892 | WHITE KNIGHT HEALTHCARE, INC. | WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) | 04/03/2001 |
| K001893 | WHITE KNIGHT HEALTHCARE, INC. | WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) | 04/02/2001 |
| K210184 | Wilson Tech (International) Limited | Wilson Tech Disposable Medical Face Mask | 09/14/2021 |
| K023755 | WINNER INDUSTRIES (SHENZHEN) CO., LTD. | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | 06/10/2003 |
| K223232 | Winner Medical Co., Ltd. | Procedure mask/Surgical mask/Face mask | 03/06/2023 |
| K220194 | Winner Medical Co., Ltd. | Procedure mask/Surgical mask/Face mask | 05/17/2022 |
| K182515 | Wuhan Dymex Healthcare Co., Ltd | Surgical Face Mask | 05/27/2019 |
| K210433 | Wuhan Dymex Healthcare Co., Ltd. | Surgical Face Mask (Ear loops and Tie-on) | 06/07/2021 |
| K221352 | Wuhan Huashida Protective Products Co., Ltd. | Surgical Face Mask | 03/13/2023 |
| K203161 | Wuhan Raytex Protection CO., LTD | Surgical Face Mask | 01/20/2022 |
| K202191 | Wuhan Zonsen Medical Products Co., Ltd | Surgical Mask | 03/29/2021 |
| K213601 | Wuhan Zonsen Medical Products Co., Ltd | Surgical Mask | 12/16/2022 |
| K210679 | Wuxi Yushou Medical Appliances Co.,Ltd. | Medical Face Mask | 01/18/2022 |
| K211576 | WYZ Medical Supplies LLC | WYZ Surgical Mask | 08/19/2021 |
| K220532 | Xiamen Blue Star Enterprise Co., Ltd. | Disposable surgical mask | 05/23/2022 |
| K210267 | Xiamen Eagledon Pharmaceutical Co., Ltd | Disposable Surgical Mask | 07/08/2021 |
| K201893 | Xiamen Probtain Medical Techology Co., LTD | Disposable Surgical Mask | 12/09/2020 |
| K202954 | Xiamen Probtain Medical Techology Co., Ltd | Disposable Surgical Mask | 07/02/2021 |
| K210698 | Xianning Eco Medical Articles Co., Ltd. | ECOMA Level 2 Disposable Surgical Mask with Ear Loops | 08/19/2021 |
| K212574 | Xiantao Deming Healthcare products Co., Ltd | Surgical Face Mask | 12/14/2021 |
| K212344 | Xiantao Dingcheng Non-woven Product Co., Ltd | Surgical Mask | 11/16/2021 |
| K221976 | Xiantao Junhui Plastic Products Co., Ltd. | Surgical Face Mask (Non-sterile) | 09/20/2022 |
| K153496 | XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. | Disposable Surgical Face Mask | 06/15/2016 |
| K222529 | Xiantao Rayxin Medical Products Co., Ltd. | Surgical Face Mask | 11/14/2022 |
| K211462 | Xiantao S&J Protective Products Co., Ltd. | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | 08/19/2021 |
| K222651 | Xiantao Sanda Industrial Co., Ltd | Surgical Face Mask | 12/13/2022 |
| K221196 | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | Disposable Medical Face Mask (ear loop) | 07/22/2022 |
| K182514 | Xiantao Zhibo Non-woven Products Co., Ltd | Surgical Face Mask | 01/24/2019 |
| K213806 | Xiantao Zhibo Nonwoven Products Co., Ltd | Disposable Medical Face Mask | 03/12/2022 |
| K203685 | Xiantao Zhongyi Safety & Protection Products Co., Ltd | Disposable Surgical Face Mask | 03/26/2021 |
| K223055 | Xiantao Zhuobo Industrial Co., LTD | Disposable Medical Face Mask | 12/05/2022 |
| K221273 | Xingyu Medical Tech Co., Ltd | Medical Face Mask (M001) | 06/28/2022 |
| K213920 | Xinxiang Kangbeier Medical Technology Co., Ltd. | Kangbeier Surgical Mask (Model: KBR-1001) | 01/16/2022 |
| K203112 | Yangzhou Runyi Arts & Crafts CO., LTD. | Disposable Medical Mask | 09/16/2021 |
| K201127 | Young Dental Manufacturing Co. 1, LLC | DEFEND Ear-loop Face Masks | 04/14/2021 |
| K172500 | YTS GLOBAL INC. | Technoweb Surgical Mask | 03/01/2018 |
| K211897 | Zhejiang Hongyu Medicali Commodity CO., LTD | Surgical Face Mask | 08/03/2021 |
| K211832 | Zhejiang Lanhine Medical Products LTD | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask | 09/08/2021 |
| K211827 | Zhejiang Lanhine Medical Products LTD | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) | 09/23/2021 |
| K202676 | Zhejiang Senhong Medical&Instrument Co., Ltd. | Disposable Medical Face Mask | 11/05/2021 |
| K211833 | Zhejiang The Purples Protective Products Co.,Ltd | Disposable Medical Face Mask | 01/16/2022 |
| K201729 | Zhende Medical Co., Ltd | Medical Mask | 12/03/2020 |
| K210020 | Zhende Medical Co., Ltd. | Medical Mask | 04/28/2021 |
| K212059 | Zhongshan Saifute Labor Protective Articles CO., LTD | Surgical Face Mask | 12/17/2021 |
| K203732 | Zhuhai Gaoge Medical Technology Co., Ltd. | Surgical Face Mask | 06/11/2021 |
| K210391 | Zhuhai Herald Datanetics Limited. | Single-use medical face mask | 07/22/2021 |
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