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
25–48 of 450
Cleared Jan 05, 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647
Customed, Inc.
General Hospital · 24d
Cleared May 27, 1997
CONVERTORS SMS DRAPES
K970554
Allegiance Healthcare Corp.
General Hospital · 103d
Cleared Mar 31, 1997
EYE TRAY
K970722
Trinity Laboratories, Inc.
General Hospital · 32d
Cleared Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142
Medline Industries, Inc.
General Hospital · 132d
Cleared Dec 23, 1996
CONVERTORS DRAPE MATERIAL
K964125
Allegiance Healthcare Corp.
General Hospital · 69d
Cleared Nov 26, 1996
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
K962205
Medline Industries, Inc.
General Hospital · 172d
Cleared Dec 13, 1995
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565
Deroyal Industries, Inc.
General Hospital · 308d
Cleared Jun 26, 1995
SURGICAL DRAPE KIT
K933148
Nobelpharma USA, Inc.
General Hospital · 727d
Cleared Nov 07, 1994
CONVERTORS ISO BAC DRAPE MATERIAL
K931267
Baxter Healthcare Corp
General Hospital · 609d
Cleared Jul 27, 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233
Depuy, Inc.
General Hospital · 134d
Cleared May 26, 1994
MEDSURG STERILE O.R. TOWELS
K940175
Medsurg Industries, Inc.
General Hospital · 135d
Cleared Apr 26, 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702
Baxter Healthcare Corp
General Hospital · 69d
Cleared Apr 11, 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101
Baxter Healthcare Corp
General Hospital · 606d
Cleared Apr 11, 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445
Storz Instrument Co.
General Hospital · 210d
Cleared Feb 09, 1994
CONTAIN-OR
K934215
Dlp, Inc.
General Hospital · 163d
Cleared Mar 03, 1993
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346
Trinity Laboratories, Inc.
General Hospital · 401d
Cleared Oct 19, 1992
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284
Trinity Laboratories, Inc.
General Hospital · 271d
Cleared Aug 17, 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518
Trinity Laboratories, Inc.
General Hospital · 195d
Cleared Aug 13, 1992
INCISSION & DRAINAGE TRAY
K921203
Trinity Laboratories, Inc.
General Hospital · 154d
Cleared Aug 13, 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204
Trinity Laboratories, Inc.
General Hospital · 154d
Cleared Aug 13, 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394
Trinity Laboratories, Inc.
General Hospital · 143d
Cleared Aug 04, 1992
QUALTEX TUBE/CORD ORGANIZER
K921350
Deroyal Industries, Inc.
General Hospital · 138d
Cleared May 31, 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995
Johnson & Johnson Medical, Inc.
General Hospital · 90d
Cleared May 11, 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517
Trinity Laboratories, Inc.
General Hospital · 97d