KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

Leading manufacturers include Surgikos, Inc., Procter & Gamble Mfg. Co. and Deroyal Industries, Inc..

450
Total
450
Cleared
109d
Avg days
1976
Since
450 devices
169–192 of 450
Cleared Dec 05, 1984
PMS DRAPE PACK
K844465
Professional Medical Services
General Hospital · 16d
Cleared Nov 07, 1984
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
K844199
Kleen Test Products
General Hospital · 8d
Cleared Oct 31, 1984
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496
Busse Hospital Disposables, Inc.
General Hospital · 55d
Cleared Aug 02, 1984
ACU-DERM TRANSPARENT INCISE DRAPE
K841735
Acme United Corp.
General Hospital · 98d
Cleared Jun 11, 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115
Kimberly-Clark Corp.
General Hospital · 47d
Cleared Jun 07, 1984
ANTIMICROBIAL INCISE DRAPE
K840957
American Convertors Div., American Pharmaseal
General Hospital · 93d
Cleared Jan 25, 1984
SINGLE-USE SURGICAL DRAPES
K833877
Procter & Gamble Mfg. Co.
General Hospital · 78d
Cleared Sep 29, 1983
LIGHT HANDLE COVER
K832278
Concept, Inc.
General Hospital · 79d
Cleared Sep 26, 1983
ISOVIS WOUND PROTECTOR
K832874
Ritmed, Inc.
General Hospital · 34d
Cleared Jun 24, 1983
ISOVIS WOUND PROTECTOR
K830270
Ritmed, Inc.
General Hospital · 150d
Cleared Jan 07, 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641
W.L. Gore & Associates, Inc.
General Hospital · 128d
Cleared Jul 22, 1982
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543
Surgikos, Inc.
General Hospital · 142d
Cleared Jun 02, 1982
SURGIKOS INCISE DRAPE
K820542
Surgikos, Inc.
General Hospital · 92d
Cleared May 12, 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850
The Kendal Co.
General Hospital · 47d
Cleared Apr 29, 1982
BOUNDARY SINGLE-USE CRANIOTOMY SHEET
K820758
The Buckeye Cellulose Corp.
General Hospital · 38d
Cleared Mar 18, 1982
DERMAFILE (CAT. # 38
K813360
Exco, Inc.
General Hospital · 108d
Cleared Mar 10, 1982
ANAGO STERILE PRODUCTS
K813097
Anago, Inc.
General Hospital · 127d
Cleared Jan 22, 1982
BOUNDARY SINGLE-USE DRAPES
K813450
The Buckeye Cellulose Corp.
General Hospital · 43d
Cleared Dec 18, 1981
BOUNDARY DRAPE TAPE
K813277
The Buckeye Cellulose Corp.
General Hospital · 25d
Cleared Nov 20, 1981
BOUNDARY SURGICAL DRAPE
K812962
The Buckeye Cellulose Corp.
General Hospital · 29d
Cleared Nov 16, 1981
BOUNDARY PROCESS CHANGE
K812738
The Buckeye Cellulose Corp.
General Hospital · 48d
Cleared Nov 06, 1981
STERILE ADHERENT DRAPES
K812809
Abco Dealers, Inc.
General Hospital · 31d
Cleared Sep 17, 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550
3M Company
General Hospital · 441d
Cleared Aug 20, 1981
BACTERICIDAL INCISE DRAPE
K811871
Surgikos, Inc.
General Hospital · 50d