FDA 510(k) Applications for Medical Device Product Code "FYC"
(Gown, Isolation, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K982369 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS | 08/24/1998 |
| K221027 | Allmed Medical (Hubei) Protective Products Co., Ltd | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | 08/12/2022 |
| K190306 | AMD Medicom Inc. | AMD Ritmed AssureWear VersaGown | 01/17/2020 |
| K954747 | AMERASIA CORP. | NIOMED BARRIER GOWNS | 03/06/1996 |
| K970814 | AMERICAN SEAL CO. | NON-STERILE ISOLATION GOWN | 05/27/1997 |
| K211538 | AZAC Group | Protect X Level 3 Isolation Gown | 11/17/2021 |
| K003749 | BANTA HEALTHCARE | 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN | 02/23/2001 |
| K160339 | Cardinal Health 200, LLC | Cardinal Health Isolation Gown | 07/28/2016 |
| K210785 | Chongqing Litai Fashion Group Limited Company | Disposable Surgical Gowns | 11/13/2021 |
| K230135 | Copioumed International Inc. | Copioumed Chemotherapy Isolation Gown | 10/04/2023 |
| K960999 | COPIOUMED INTL., INC. | ISOLATION GOWN | 12/30/1996 |
| K212422 | Crown Name Disposable Hygiene Products Fty.Ltd. | Disposable Surgical Isolation Gown | 04/29/2022 |
| K971702 | FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD | FAR-EAST BARRIER GOWNS | 07/08/1997 |
| K210148 | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinfor | 04/13/2022 |
| K212698 | Foshan Nanhai Plus Medical Co Ltd | Plus Medical Isolation Gown Level 3 | 03/02/2022 |
| K954549 | GLOBAL HEALTHCARE, INC. | SURGICAL APPAREL | 04/18/1996 |
| K210131 | GRI-Alleset, Inc | ComfortGuard Surgical Isolation Gown | 08/26/2021 |
| K213832 | Hubei Xinxin Non-woven Co., Ltd. | AAMI3 Isolation Gown | 05/16/2022 |
| K214116 | Hubei Xinxin Non-woven Co.,Ltd. | AAMI4 Isolation Gown | 10/11/2022 |
| K171535 | Jingzhou Haixin Green Cross Medical Products Co., Ltd | SURGICAL ISOLATION GOWN | 02/15/2018 |
| K212504 | Kenpax International Limited | Isolation Gown AAMI Level 3 | 11/07/2021 |
| K972410 | KENTRON HEALTH CARE, INC. | IMPERVIOUS ISOLATION GOWN | 09/19/1997 |
| K971917 | KENTRON HEALTH CARE, INC. | KENTRON'S ISOLATION GOWN | 09/19/1997 |
| K160471 | MEDLINE INDUSTRIES, INC. | Medline Non-Surgical Isolation Gown- | 01/31/2017 |
| K210414 | Medtecs (Taiwan) Corp. | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | 10/21/2022 |
| K223467 | Nanning TECBOD Biological Technology Co.,Ltd. | Disposable Isolation Gown | 02/10/2023 |
| K212717 | Paneffort, LLC | Paneffort AAMI Level 3 Isolation Gown | 11/30/2022 |
| K160361 | PRIMED MEDICAL PRODUCTS INC. | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | 11/04/2016 |
| K212633 | String King Lacrosse, LLC | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | 11/24/2021 |
| K202310 | Wildcat PPE, LLC | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back | 01/29/2021 |
| K220528 | Wuhan Dymex Healthcare Co., Ltd. | Surgical Isolation Cover Gown | 06/10/2022 |
| K212357 | Wuhan Zonsen Medical Products Co., Ltd | Surgical isolation gown | 01/20/2022 |
| K223304 | Xiamen Probtain Medical Technology Co., Ltd | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | 02/08/2023 |
| K223411 | Xiamen Probtain Medical Techology Co., Ltd | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | 01/04/2023 |
| K203415 | Yanbian Pacific Textile Co., LTD | Surgical Isolation Gown | 05/20/2021 |
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