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
49–72 of 450
Cleared Feb 05, 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486
Deroyal Industries, Inc.
General Hospital · 183d
Cleared Dec 02, 1991
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369
Deroyal Industries, Inc.
General Hospital · 62d
Cleared Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506
Baxter Healthcare Corp
General Hospital · 65d
Cleared Feb 19, 1991
QUALTEX SURGICAL DRAPE
K910495
Deroyal Industries, Inc.
General Hospital · 14d
Cleared Jan 02, 1991
CUSTOMED CARDIOVASCULAR PACK
K904693
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694
Customed, Inc.
General Hospital · 78d
Cleared Dec 13, 1990
QUALTEX SURGICAL DRAPE
K904960
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Oct 31, 1990
CUSTOMED CYSTO PACK II
K901705
Customed, Inc.
General Hospital · 202d
Cleared Oct 31, 1990
CUSTOMED LAP PACK II
K902191
Customed, Inc.
General Hospital · 168d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK I
K902884
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK II
K902885
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK III
K902886
Customed, Inc.
General Hospital · 79d
Cleared Jul 12, 1990
CUSTOMED LAP PACK I
K902029
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
CUSTOMED LAP PACK III
K902030
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
CUSTOMED LAP PACK IV
K902031
Customed, Inc.
General Hospital · 69d
Cleared Apr 20, 1989
SURGICAL 'LASER' DRAPE
K884231
Henley Intl.
General Hospital · 195d
Cleared Mar 03, 1989
AM TM SYRGICAL DRAPES
K882643
Henley Intl.
General Hospital · 249d
Cleared Dec 17, 1987
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086
3M Company
General Hospital · 71d
Cleared Oct 23, 1987
LASER RESISTANT DRAPE
K873141
Baxter Healthcare Corp
General Hospital · 74d
Cleared Jul 28, 1987
OPSITE SPECIALITY DRAPES
K872757
Smith & Nephew, Inc.
General Hospital · 15d
Cleared Feb 20, 1987
MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
K864388
Deroyal Industries, Inc.
General Hospital · 106d
Cleared Aug 07, 1986
SPUNGUARD PLUS SURGICAL DRAPE
K862801
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Jun 04, 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969
Deroyal Industries, Inc.
General Hospital · 15d
Cleared Apr 30, 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196
Deroyal Industries, Inc.
General Hospital · 30d