FYC · Class II · 21 CFR 878.4040

FDA Product Code FYC: Gown, Isolation, Surgical

Leading manufacturers include American Hospital Supply Corp., Hubei Xinxin Non-Woven Co., Ltd. and Owens & Minor (O&M) Halyard, Inc..

68
Total
68
Cleared
180d
Avg days
1976
Since
68 devices
25–48 of 68
Cleared Jan 31, 2017
Medline Non-Surgical Isolation Gown-
K160471
Medline Industries, Inc.
General Hospital · 347d
Cleared Jul 28, 2016
Cardinal Health Isolation Gown
K160339
Cardinal Health200, LLC
General Hospital · 171d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared May 10, 1995
BUSE STAFF PROTECTION GOWNS AND KITS
K941845
Busse Hospital Disposables, Inc.
General Hospital · 391d
Cleared Dec 30, 1987
ISOLATION GOWN
K874888
Sage Products, Inc.
General Hospital · 29d
Cleared Mar 19, 1984
CONTROL COVER GOWN
K840229
Kimberly-Clark Corp.
General Hospital · 59d
Cleared May 23, 1980
BARRIER PLUS SURGEON GOWNS
K801162
American Hospital Supply Corp.
General Hospital · 8d
Cleared May 09, 1978
ISOLATION GOWN
K780605
Abco Dealers, Inc.
General Hospital · 29d
Cleared Jan 28, 1977
ISOLATION GOWN PACK
K761080
American Hospital Supply Corp.
General Hospital · 70d
Cleared Dec 30, 1976
CLEANING AND ISOLATION ROOM KIT
K760904
American Hospital Supply Corp.
General Hospital · 65d