FYA · Class II · 21 CFR 878.4040

FDA Product Code FYA: Gown, Surgical

FDA product code FYA covers surgical gowns worn by members of the surgical team during operative procedures.

These disposable or reusable gowns provide a sterile barrier that protects both the patient from microbial contamination and the healthcare worker from exposure to blood and body fluids. They are classified by barrier performance level — from minimal to highest protection — based on the expected fluid exposure.

FYA devices are Class II medical devices, regulated under 21 CFR 878.4040 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Standard Textile Co., Inc., Medline Industries, Inc. and Kimberly-Clark Corp..

298
Total
298
Cleared
165d
Avg days
1976
Since
298 devices
169–192 of 298
Cleared Sep 24, 2001
BREATHABLE IMPERVIOUS GOWNS
K012984
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799
Standard Textile Co., Inc.
General Hospital · 83d
Cleared Feb 16, 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755
Medline Industries, Inc.
General Hospital · 73d
Cleared Oct 26, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/FS
K003194
Stackhouse, Inc.
General Hospital · 14d
Cleared Aug 17, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/F
K000605
Stackhouse, Inc.
General Hospital · 176d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 05, 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
K000901
Molnlycke Health Care, Inc.
General Hospital · 106d
Cleared Apr 21, 2000
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Mar 02, 2000
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170
Medline Industries, Inc.
General Hospital · 162d
Cleared Feb 18, 2000
MED-GUARD SURGEON'S GOWN
K992445
Kappler USA
General Hospital · 211d
Cleared Feb 18, 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Jan 20, 2000
GOWN BACK, MODEL 13-403N
K992436
Techstyles
General Hospital · 182d
Cleared Dec 20, 1999
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053
Stryker Instruments
General Hospital · 20d
Cleared Oct 15, 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148
Stryker Instruments
General Hospital · 24d
Cleared Sep 22, 1999
CONVERTORS SURGICAL GOWNS
K992951
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Aug 12, 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514
Allegiance Healthcare Corp.
General Hospital · 15d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Apr 13, 1999
BARRIER SURGICAL GOWNS
K990395
Johnson & Johnson Medical, Div. of Ethicon, Inc.
General Hospital · 63d
Cleared Apr 02, 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422
Medical Sterilization, Inc.
General Hospital · 113d
Cleared Jan 14, 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058
Encompass Group, LLC
General Hospital · 217d
Cleared Dec 14, 1998
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694
Medline Industries, Inc.
General Hospital · 133d
Cleared Nov 30, 1998
ROTECNO 2000 SURGICAL GOWN
K982059
Encompass Group, LLC
General Hospital · 172d
Cleared Oct 28, 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693
Medline Industries, Inc.
General Hospital · 86d
Cleared Jul 10, 1998
MICROCOOL SURGICAL GOWN
K981393
Kimberly-Clark Corp.
General Hospital · 84d