FDA 510(k) Applications for Medical Device Product Code "LZC"
(Patient Examination Glove, Specialty)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200633 | 0 & M Halyard, Inc | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 10/11/2020 |
| K010211 | ALLEGIANCE HEALTHCARE CORP. | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES | 02/15/2001 |
| K990677 | AMPRI RUBBERWARE INDUSTRIES SDN BHD | ABSOGEL CHEMOTHERAPHY GLOVES | 11/01/1999 |
| K213325 | Anhui Xinyisheng Medical Technology Co., Ltd | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | 01/28/2022 |
| K213076 | Aspen Glove Sdn. Bhd. | AspenMed+ | 12/20/2021 |
| K222449 | Better Care Plastic Technology Co., Ltd. | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | 08/27/2022 |
| K162186 | BRIGHTWAY HOLDINGS SDN BHD | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | 03/31/2017 |
| K033789 | Cardinal Health | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING | 05/07/2004 |
| K032444 | Cardinal Health | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | 11/13/2003 |
| K162858 | Careplus (M) SDN BHD | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | 07/24/2017 |
| K172525 | Central Medicare Sdn. Bhd. | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | 11/13/2017 |
| K173942 | Central Medicare Sdn. Bhd. | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | 03/05/2018 |
| K183149 | Central Medicare Sdn. Bhd. | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | 07/04/2019 |
| K172642 | Central Medicare Sdn. Bhd. | Orange Non Sterile Powder Free Nitrile Examination Gloves | 11/28/2017 |
| K213910 | Changzhou Universal Medical Equipment Co. Ltd | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | 03/10/2022 |
| K180476 | Comfort Rubber Gloves Industries Sdn. Bhd. | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | 05/15/2018 |
| K982832 | EMERSON & CO. S.R.L. | PROGUARD, RR-1, RR-2 | 12/23/1998 |
| K183562 | Encompass Industries Sdn. Bhd. | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | 10/23/2019 |
| K193555 | Ever Global (Vietnam) Enterprise Corp | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | 06/04/2020 |
| K163017 | GMP MEDICARE SDN BHD | Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | 03/22/2017 |
| K152222 | GMP MEDICARE SDN BHD (F25) | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs | 04/21/2016 |
| K182382 | GMP Medicare SDN BHD (F25) | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | 08/29/2019 |
| K091643 | GX CORPORATION SDN BHD | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | 11/02/2009 |
| K220491 | Hainan Asther Medical Equipment Co., Ltd | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | 05/14/2022 |
| K180646 | Halyard Health | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | 06/27/2018 |
| K160709 | Halyard Health | HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves | 09/06/2016 |
| K120336 | HARTALEGA SDN BHD | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U | 06/25/2012 |
| K163146 | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | 02/13/2017 |
| K181130 | Hebei Titans Hongsen Medical Technology Co., LTD. | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | 08/10/2018 |
| K220545 | HL Rubber Industries Sdn bhd | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | 05/26/2022 |
| K212639 | Jiangsu Nanfang Medical Co., Ltd | Disposable Medical Nitrile Examination Gloves (Non sterile) | 12/08/2021 |
| K221157 | JR Engineering & Medical Technologies (M) SDN.BHD. | JR Medic | 08/30/2022 |
| K212827 | JR Engineering & Medical Technologies (M) SDN.BHD. | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | 12/06/2021 |
| K101596 | KIMBERLY-CLARK | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | 07/21/2010 |
| K081089 | KIMBERLY-CLARK CORP. | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | 07/14/2008 |
| K062764 | KOSSAN LATEX INDUSTRIES(M)SDN BHD | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | 02/27/2007 |
| K102189 | LATEXX MANUFACTURING SDN.BHD. | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM | 03/14/2012 |
| K172864 | Maxter Glove Manufacturing Sdn Bhd | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | 05/02/2018 |
| K151390 | MAXTER GLOVE MANUFACTURING SDN BHD | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs | 05/02/2016 |
| K201390 | Medline Industires, Inc. | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | 09/18/2020 |
| K072197 | METACURE SURGICAL GLOVES SDN BHD | POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR | 03/12/2008 |
| K081971 | NITRITEX (M) SDN. BHD. | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES | 12/23/2008 |
| K220353 | Niujian Technology Co., Ltd | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | 03/31/2022 |
| K121926 | NORTHSTAR HEALTHCARE HOLDINGS | BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM | 09/20/2012 |
| K183132 | O & M Halyard, Inc. | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | 02/05/2019 |
| K191230 | O & M Halyard, Inc. | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | 11/08/2019 |
| K102790 | PERUSAHAAN GETAH ASAS SDN BHD | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | 11/29/2010 |
| K042805 | PERUSAHAAN GETAH ASAS SDN BHD | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE | 12/16/2004 |
| K032374 | PERUSAHAAN GETAH ASAS SDN BHD | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | 10/22/2003 |
| K992162 | SAFESKIN CORP. | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | 08/30/1999 |
| K970135 | SAGE PRODUCTS, INC. | NITRILE GLOVES | 08/25/1997 |
| K101822 | SGMP CO., LTD. | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | 11/19/2010 |
| K101436 | SHEN WEI (USA), INC. | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | 11/17/2010 |
| K121811 | SHEN WEI (USA), INC. | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | 11/21/2012 |
| K173766 | Shen Wei USA Inc. | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | 07/08/2018 |
| K190159 | Showa Best Glove, Inc. | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | 05/06/2019 |
| K093500 | WEAR SAFE (MALAYSIA) SDN. BHD. | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE | 01/19/2010 |
| K141982 | WRP ASIA PACIFIC SDN. BHD. | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | 02/05/2015 |
| K083409 | WRP ASIA PACIFIC SDN. BHD. | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL | 07/29/2009 |
| K083410 | WRP ASIA PACIFIC SDN. BHD. | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM | 07/31/2009 |
| K083305 | WRP ASIA PACIFIC SDN. BHD. | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM | 06/18/2009 |
| K083408 | WRP ASIA PACIFIC SDN. BHD. | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | 07/31/2009 |
| K182383 | YTY Industry (Manjung) Sdn Bhd | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | 03/19/2019 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
