Drape, Surgical, Antimicrobial
FDA product code KKX · 442 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4370
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-11 – 2023-10-25
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
KKX
1998-05-15
KKX
1998-03-13
MSI SURGICAL DRAPES
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KKX
1998-02-26
PROMAX SURGICAL DRAPES AND COVERS
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KKX
1998-01-05
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
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KKX
1997-12-04
MENTOR SUPER ABSORBENT DRAPE
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KKX
1997-10-20
ULTRASOUND TRANSDUCER DRAPE
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KKX
1997-09-16
OPPORTUNITY, INC. LACERATION TRAY
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KKX
1997-09-09
BOUFFANT CAP
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KKX
1997-08-22
DRAPE, SURGICAL-LATEX
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KKX
1997-06-24
SURGICAL DRAPES
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KKX
1997-05-27
CONVERTORS SMS DRAPES
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KKX
1997-04-10
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
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KKX
1997-03-31
EYE TRAY
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KKX
1997-02-25
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
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KKX
1997-01-27
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
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KKX
1996-12-23
CONVERTORS DRAPE MATERIAL
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KKX
1996-11-26
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
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KKX
1996-11-22
TEX-CARE STERILE STOCKINETTE
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KKX
1996-07-18
TUAT SPLATTER CONTROL SHIELD SCS-300
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KKX
1996-07-12
RX TEXTILES STERILE STOCKINETTE
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KKX
1996-06-05
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
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KKX
1996-04-23
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
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KKX
1996-03-12
CPR EYE TRAY
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KKX
1996-03-12
VOLMED OPERATION DRAPE
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KKX
1995-12-13
DEROYAL SURGICAL INSTRUMENT DRAPE
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KKX
1995-10-23
CONTAMINATION CONTAINMENT DRAPE
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KKX
1995-09-29
TOWEL PACK
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KKX
1995-09-22
ORS-111
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KKX
1995-06-26
SURGICAL DRAPE KIT
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KKX
1995-05-25
OREX(R) O.R EQUIPMENT DRAPES
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KKX
1995-05-16
STERILE EQUIPMENT COVER
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KKX
1995-05-03
STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP
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KKX
1995-05-03
OR TOWEL
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KKX
1995-04-27
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
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KKX
1995-03-28
THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
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KKX
1995-02-28
SPLATTER CONTROL SHIELD
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KKX
1995-02-28
COMPEL SURGICALDRAPES
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KKX
1995-02-28
OREX SURGICAL DRAPES
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KKX
1995-02-08
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
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KKX
1995-02-02
3M X-LARGE SHEET #7979/ #7979NS
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KKX
1995-02-02
CIVCO PROBE BOOT/CORD COVER
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KKX
1995-01-02
ASEP PLUS SURGICAL DRAPES
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KKX
1994-12-20
OREX O.R. TOWEL
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KKX
1994-11-07
CONVERTORS ISO BAC DRAPE MATERIAL
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KKX
1994-10-28
UNIVERSAL VIDEO/LASER ARM DRAPE
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KKX
1994-10-07
UPPER EXTERMITY DRAPE KIT
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KKX
1994-09-08
AMSCO STERILE RECOVERIES ABSORBENT TOWELS
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KKX
1994-09-07
SURGICAL DRAPES
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KKX
1994-07-27
GLOBAL SHOULDER O.R. DRAPE PACK
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KKX
1994-06-13
SURGICAL DRAPES, MODIFICATION
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KKX
1994-05-26
MEDSURG STERILE O.R. TOWELS
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KKX
1994-05-12
STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE
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KKX
1994-05-05
HEAD SHEET
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KKX
1994-05-05
SURGICAL DRAPE
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KKX
1994-05-05
ABDOMINAL / THORACIC PATIENT DRAPE
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KKX
1994-04-26
CONVERTORS OPTI-SORB DRAPE MATERIAL
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KKX
1994-04-11
STSTORZ DP5300 AND DP9502 STERILE DRAPES
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KKX
1994-04-11
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
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KKX
1994-02-09
CONTAIN-OR
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KKX
1994-02-03
NPAC
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KKX
1994-02-03
ARTHROBOT BI-FOLD DRAPE
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KKX
1994-02-03
DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252
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KKX
1994-01-27
IMC CABLE/WIRE COVER
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KKX
1993-09-13
ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.
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KKX
1993-09-07
DRAPES
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KKX
1993-07-06
BARRIER SAF-TE HYDROGEL DRAPE
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KKX
1993-03-23
VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE
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KKX
1993-03-23
VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS,
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KKX
1993-03-18
VASECTOMY DRAPE
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KKX
1993-03-03
DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
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KKX
1993-03-03
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
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KKX
1993-02-23
COMPEL SURGICAL DRAPES
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KKX
1993-02-19
OB/GYN DRAPE
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KKX
1993-01-27
SURGICAL GOWN PACK
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KKX
1993-01-27
N-PAC
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KKX
1993-01-04
SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT
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KKX
1992-10-19
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
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KKX
1992-10-01
SURGICAL DRAPE
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KKX
1992-09-28
ULCER WOUND TRAY
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KKX
1992-08-17
E.R. SUTURE TRAY, STERILE, DISPOSABLE
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KKX
1992-08-13
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
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KKX
1992-08-13
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
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KKX
1992-08-13
INCISSION & DRAINAGE TRAY
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KKX
1992-08-04
QUALTEX TUBE/CORD ORGANIZER
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KKX
1992-07-02
DURATECH HOSPITAL TOWEL
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KKX
1992-06-22
DISPOSABLE O.R. TOWEL, STERILE
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KKX
1992-05-31
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
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KKX
1992-05-11
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
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KKX
1992-04-23
LACERATION TRAYS
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KKX
1992-04-23
SUTURE REMOVAL KIT
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KKX
1992-04-06
KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES
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KKX
1992-04-03
HEALTH PAK TRAY SOX BARRIERS
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KKX
1992-03-12
STERILE PLASTIC DRAPE
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KKX
1992-02-07
DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
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KKX
1992-02-07
DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
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KKX
1992-02-05
QUALTEX SURGICAL DRAPE, MODIFICATION
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KKX
1992-01-31
LACERATION TRAY
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KKX
1992-01-15
MULTIPLE STERILE SURGICAL DRAPE PACK
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KKX
1992-01-09
ARTHROSCOPY CAMERA DRAPE
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KKX
1991-12-02
QUALTEX MAGNETIC INSTRUMENT DRAPE
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