KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

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

450
Total
450
Cleared
109d
Avg days
1976
Since
450 devices
73–96 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 Dec 04, 1997
MENTOR SUPER ABSORBENT DRAPE
K973146
Mentor Ophthalmics, Inc.
General Hospital · 104d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970889
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Sep 16, 1997
OPPORTUNITY, INC. LACERATION TRAY
K971089
Opportunity, Inc.
General Hospital · 176d
Cleared Sep 09, 1997
BOUFFANT CAP
K972187
American Seal Co.
General Hospital · 91d
Cleared Aug 22, 1997
DRAPE, SURGICAL-LATEX
K970891
Protek Medical Products, Inc.
General Hospital · 164d
Cleared Jun 24, 1997
SURGICAL DRAPES
K971159
International Medsurg Connection
General Hospital · 85d
Cleared May 27, 1997
CONVERTORS SMS DRAPES
K970554
Allegiance Healthcare Corp.
General Hospital · 103d
Cleared Apr 10, 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185
Contour Fabricators, Inc.
General Hospital · 83d
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 Jan 27, 1997
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
K963675
Micro-Medical Devices, Inc.
General Hospital · 136d
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 Nov 22, 1996
TEX-CARE STERILE STOCKINETTE
K955749
Flynt Amtex, Inc.
General Hospital · 339d
Cleared Jul 18, 1996
TUAT SPLATTER CONTROL SHIELD SCS-300
K962003
Taut, Inc.
General Hospital · 57d
Cleared Jul 12, 1996
RX TEXTILES STERILE STOCKINETTE
K960803
Rx Textiles, Inc.
General Hospital · 136d
Cleared Jun 05, 1996
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
K960045
The Sewing Source, Inc.
General Hospital · 155d
Cleared Apr 23, 1996
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
K954824
Medical Creative Technologies, Inc.
General Hospital · 186d
Cleared Mar 12, 1996
VOLMED OPERATION DRAPE
K955872
Medal Intl. Sales Co., LLC
General Hospital · 75d
Cleared Mar 12, 1996
CPR EYE TRAY
K960242
Custom Pack Reliability
General Hospital · 56d
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 May 25, 1995
OREX(R) O.R EQUIPMENT DRAPES
K945755
Thantex Specialties, Inc.
General Hospital · 183d