FDA Product Code FYC: Gown, Isolation, Surgical
Leading manufacturers include Hubei Xinxin Non-Woven Co., Ltd., Xiamen Probtain Medical Techology Co., Ltd. and Nanning Tecbod Biological Technology Co., Ltd..
68
Total
68
Cleared
180d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 10 in the prior period
FDA 510(k) Cleared Gown, Isolation, Surgical Devices (Product Code FYC)
68 devices
Cleared
May 16, 2024
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.
General Hospital
245d
Cleared
Oct 04, 2023
Copioumed Chemotherapy Isolation Gown
Copioumed International, Inc.
General Hospital
259d
Cleared
Feb 10, 2023
Disposable Isolation Gown
Nanning Tecbod Biological Technology Co., Ltd.
General Hospital
85d
Cleared
Feb 08, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Technology Co., Ltd.
General Hospital
104d
Cleared
Jan 04, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Techology Co., Ltd.
General Hospital
56d
Cleared
Nov 30, 2022
Paneffort AAMI Level 3 Isolation Gown
Paneffort, LLC
General Hospital
460d
Cleared
Oct 21, 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
Medtecs (Taiwan) Corp.
General Hospital
617d
Cleared
Oct 11, 2022
AAMI4 Isolation Gown
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital
285d
Cleared
Aug 12, 2022
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Allmed Medical (Hubei) Protective Products Co., Ltd.
General Hospital
128d
Cleared
Jun 10, 2022
Surgical Isolation Cover Gown
Wuhan Dymex Healthcare Co., Ltd.
General Hospital
106d
Cleared
May 16, 2022
AAMI3 Isolation Gown
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital
158d
Cleared
Apr 29, 2022
Disposable Surgical Isolation Gown
Crown Name Disposable Hygiene Products Fty., Ltd.
General Hospital
268d
Cleared
Apr 13, 2022
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-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
General Hospital
447d
Cleared
Mar 02, 2022
Plus Medical Isolation Gown Level 3
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital
189d
Cleared
Jan 20, 2022
Surgical isolation gown
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital
175d
Cleared
Nov 24, 2021
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
String King Lacrosse, LLC
General Hospital
97d
Cleared
Nov 17, 2021
Protect X Level 3 Isolation Gown
Azac Group
General Hospital
183d
Cleared
Nov 13, 2021
Disposable Surgical Gowns
Chongqing Litai Fashion Group Limited Company
General Hospital
242d
Cleared
Nov 07, 2021
Isolation Gown AAMI Level 3
Kenpax International Limited
General Hospital
90d
Cleared
Aug 26, 2021
ComfortGuard Surgical Isolation Gown
Gri-Alleset, Inc.
General Hospital
219d
About Product Code FYC - Regulatory Context
510(k) Submission Activity
68 total 510(k) submissions under product code FYC since 1976, with 68 receiving FDA clearance (average review time: 180 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 10 in the prior period.
FYC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →