Panels › General, Plastic Surgery › Product code FYC · Class 2
Gown, Isolation, Surgical
Regulation 878.4040
0510(k)s in 12 months (68 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FYC
| Company | 510(k)s | Recalls |
|---|---|---|
| American Threshold Industries, Inc. | 4 | 0 |
| American Hospital Supply Corp. | 3 | 0 |
| Amsco Sterile Recoveries, Inc. | 2 | 0 |
| Cardinal Health 200, LLC | 0 | 2 |
| Dynatech Medical Products | 2 | 0 |
| Hubei Xinxin Non-Woven Co., Ltd. | 2 | 0 |
| Kentron Health Care, Inc. | 2 | 0 |
| Medtek Development Corp. | 2 | 0 |
| A Plus International, Inc. | 1 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2024 | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) Owens & Minor (O&M) Halyard, Inc. | FYC |
| Oct 4, 2023 | K230135 | Copioumed Chemotherapy Isolation Gown Copioumed International, Inc., TW | FYC |
| Feb 10, 2023 | K223467 | Disposable Isolation Gown Nanning Tecbod Biological Technology Co., Ltd., CN | FYC |
| Feb 8, 2023 | K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) Xiamen Probtain Medical Technology Co., Ltd., CN | FYC |
| Jan 4, 2023 | K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) Xiamen Probtain Medical Techology Co., Ltd., CN | FYC |
| Nov 30, 2022 | K212717 | Paneffort AAMI Level 3 Isolation Gown Paneffort, LLC | FYC |
| Oct 21, 2022 | K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown Medtecs (Taiwan) Corp., TW | FYC |
| Oct 11, 2022 | K214116 | AAMI4 Isolation Gown Hubei Xinxin Non-Woven Co., Ltd., CN | FYC |
| Aug 12, 2022 | K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) Allmed Medical (Hubei) Protective Products Co., Ltd., CN | FYC |
| Jun 10, 2022 | K220528 | Surgical Isolation Cover Gown Wuhan Dymex Healthcare Co., Ltd., CN | FYC |
| May 16, 2022 | K213832 | AAMI3 Isolation Gown Hubei Xinxin Non-Woven Co., Ltd., CN | FYC |
| Apr 29, 2022 | K212422 | Disposable Surgical Isolation Gown Crown Name Disposable Hygiene Products Fty., Ltd., CN | FYC |
| Apr 13, 2022 | K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gow Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti., TR | FYC |
| Mar 2, 2022 | K212698 | Plus Medical Isolation Gown Level 3 Foshan Nanhai Plus Medical Co, Ltd., CN | FYC |
| Jan 20, 2022 | K212357 | Surgical isolation gown Wuhan Zonsen Medical Products Co., Ltd., CN | FYC |
| Nov 24, 2021 | K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue String King Lacrosse, LLC | FYC |
| Nov 17, 2021 | K211538 | Protect X Level 3 Isolation Gown Azac Group | FYC |
| Nov 13, 2021 | K210785 | Disposable Surgical Gowns Chongqing Litai Fashion Group Limited Company, CN | FYC |
| Nov 7, 2021 | K212504 | Isolation Gown AAMI Level 3 Kenpax International Limited, CN | FYC |
| Aug 26, 2021 | K210131 | ComfortGuard Surgical Isolation Gown Gri-Alleset, Inc. | FYC |
| May 20, 2021 | K203415 | Surgical Isolation Gown Yanbian Pacific Textile Co., Ltd., CN | FYC |
| Jan 29, 2021 | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back Wildcat Ppe, LLC | FYC |
| Jan 17, 2020 | K190306 | AMD Ritmed AssureWear VersaGown Amd Medicom, Inc., CA | FYC |
| Feb 15, 2018 | K171535 | SURGICAL ISOLATION GOWN Jingzhou Haixin Green Cross Medical Products Co., Ltd., CN | FYC |
| Jan 31, 2017 | K160471 | Medline Non-Surgical Isolation Gown- Medline Industries, Inc. | FYC |
| Nov 4, 2016 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) Primed Medical Products, Inc., CA | FYC |
| Jul 28, 2016 | K160339 | Cardinal Health Isolation Gown Cardinal Health200, LLC | FYC |
| Feb 23, 2001 | K003749 | 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN Banta Healthcare | FYC |
| Aug 24, 1998 | K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS Allegiance Healthcare Corp. | FYC |
| Sep 19, 1997 | K972410 | IMPERVIOUS ISOLATION GOWN Kentron Health Care, Inc. | FYC |
| Sep 19, 1997 | K971917 | KENTRON'S ISOLATION GOWN Kentron Health Care, Inc. | FYC |
| Jul 8, 1997 | K971702 | FAR-EAST BARRIER GOWNS Far East Science & Technology Development Co., Ltd. | FYC |
| May 27, 1997 | K970814 | NON-STERILE ISOLATION GOWN American Seal Co. | FYC |
| Dec 30, 1996 | K960999 | ISOLATION GOWN Copioumed Intl., Inc., TW | FYC |
| Apr 18, 1996 | K954549 | SURGICAL APPAREL Global Healthcare, Inc. | FYC |
| Mar 6, 1996 | K954747 | NIOMED BARRIER GOWNS Amerasia Corp. | FYC |
| Sep 25, 1995 | K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN American Threshold Industries, Inc. | FYC |
| Sep 25, 1995 | K952114 | KOOL GARD SINGLES GOWN American Threshold Industries, Inc. | FYC |
| Sep 5, 1995 | K952116 | COVER GOWN American Threshold Industries, Inc. | FYC |
| May 17, 1995 | K942351 | DI ISOLATION GOWN Derekduck Industries Corp., CN | FYC |
| May 10, 1995 | K941845 | BUSE STAFF PROTECTION GOWNS AND KITS Busse Hospital Disposables, Inc. | FYC |
| Apr 25, 1995 | K945223 | OREX ISOLATION GOWN Thantex Specialties, Inc. | FYC |
| Jun 10, 1994 | K931145 | NON-STERILE ISOLATION GOWN Amsco Sterile Recoveries, Inc. | FYC |
| Apr 4, 1994 | K923162 | TBC TRAUMA SUIT PROTECTIVE GOWN Tbc, Inc. | FYC |
| Oct 12, 1993 | K922442 | ISOLATION GOWNS Pfb Inter-Apparel Corp. | FYC |
| Oct 4, 1993 | K930026 | POLY-MED DISPOSABLE PERSONAL PROTECTION KIT Medtek Development Corp. | FYC |
| Aug 16, 1993 | K925077 | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS Medtek Development Corp. | FYC |
| Jan 29, 1993 | K923188 | DYNASTY IMPERVIOUS ISOLATION J-SUIT Dynatech Medical Products | FYC |
| Aug 18, 1992 | K920404 | SURGEON'S GOWN Amsco Sterile Recoveries, Inc. | FYC |
| Aug 11, 1992 | K922234 | DYNASTY ISOLATION GOWN Dynatech Medical Products | FYC |
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