FYC · Class II · 21 CFR 878.4040

FDA Product Code FYC: Gown, Isolation, Surgical

Leading manufacturers include American Threshold Industries, Inc., American Hospital Supply Corp. and Kentron Health Care, 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 Nov 04, 2016
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361
Primed Medical Products, Inc.
General Hospital · 269d
Cleared Jul 28, 2016
Cardinal Health Isolation Gown
K160339
Cardinal Health200, LLC
General Hospital · 171d
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749
Banta Healthcare
General Hospital · 81d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Sep 19, 1997
KENTRON'S ISOLATION GOWN
K971917
Kentron Health Care, Inc.
General Hospital · 119d
Cleared Sep 19, 1997
IMPERVIOUS ISOLATION GOWN
K972410
Kentron Health Care, Inc.
General Hospital · 85d
Cleared Jul 08, 1997
FAR-EAST BARRIER GOWNS
K971702
Far East Science & Technology Development Co., Ltd.
General Hospital · 61d
Cleared May 27, 1997
NON-STERILE ISOLATION GOWN
K970814
American Seal Co.
General Hospital · 82d
Cleared Dec 30, 1996
ISOLATION GOWN
K960999
Copioumed Intl., Inc.
General Hospital · 293d
Cleared Apr 18, 1996
SURGICAL APPAREL
K954549
Global Healthcare, Inc.
General Hospital · 199d
Cleared Mar 06, 1996
NIOMED BARRIER GOWNS
K954747
Amerasia Corp.
General Hospital · 142d
Cleared Sep 25, 1995
KOOL GARD SINGLES GOWN
K952114
American Threshold Industries, Inc.
General Hospital · 143d
Cleared Sep 25, 1995
BARRIER GOWN, KOOL-GARD BACKLESS GOWN
K952115
American Threshold Industries, Inc.
General Hospital · 143d
Cleared Sep 05, 1995
COVER GOWN
K952116
American Threshold Industries, Inc.
General Hospital · 123d
Cleared May 10, 1995
BUSE STAFF PROTECTION GOWNS AND KITS
K941845
Busse Hospital Disposables, Inc.
General Hospital · 391d
Cleared Apr 25, 1995
OREX ISOLATION GOWN
K945223
Thantex Specialties, Inc.
General Hospital · 181d
Cleared Dec 30, 1987
ISOLATION GOWN
K874888
Sage Products, Inc.
General Hospital · 29d
Cleared Dec 02, 1987
MAXIMUM CONTROL GOWN
K874318
Ulti-Med Intl., Inc.
General Hospital · 43d
Cleared May 17, 1985
DISPOSABLE ISOLATION GOWN
K851823
American Threshold Industries, Inc.
General Hospital · 21d
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