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
1986-03-15
KKX
1986-02-21
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
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KKX
1986-02-19
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
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KKX
1986-02-19
100% COTTON ABSORBENT TOWEL
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KKX
1985-09-05
MAI STERILE UTILITY DRAPE
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KKX
1985-07-29
HUCK TOWEL
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KKX
1985-07-09
DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)
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KKX
1985-05-03
STERILE DISPOSABLE PN DRAPE SYSTEM
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KKX
1985-05-01
ABCO DRAPES/TOWELS
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KKX
1985-02-26
STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
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KKX
1985-02-21
POLY-LINED TOWEL/DRAPE LINE
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KKX
1985-01-14
SURGICAL DRAPES
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KKX
1985-01-10
I.V. START KIT & OBSTETRICAL KIT
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KKX
1984-12-05
PMS DRAPE PACK
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KKX
1984-11-07
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
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KKX
1984-10-31
DRAPE SURGICAL UTILITY DRAPE STERILE
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KKX
1984-09-21
ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
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KKX
1984-08-02
ACU-DERM TRANSPARENT INCISE DRAPE
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KKX
1984-08-01
ALL-HANDS STERILE FIELD-0201
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KKX
1984-06-11
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
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KKX
1984-06-07
ANTIMICROBIAL INCISE DRAPE
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KKX
1984-04-04
SDI SURGICAL DRAPE
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KKX
1984-01-25
SINGLE-USE SURGICAL DRAPES
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KKX
1984-01-25
BURLINGTON ANTIMICROBIAL STOCKINEETTE
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KKX
1984-01-25
BURLINGTON STERILE ANTIMICROBIAL STOCK
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KKX
1983-10-14
E-Z FIT
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KKX
1983-09-29
LIGHT HANDLE COVER
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KKX
1983-09-26
ISOVIS WOUND PROTECTOR
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KKX
1983-06-24
ISOVIS WOUND PROTECTOR
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KKX
1983-04-12
REDI-DRAPE
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KKX
1983-03-17
STERILE SURGICAL DRAPES
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KKX
1983-01-12
DRAPE, SURGICAL ANGIOGRAPHY
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KKX
1983-01-07
GORE-TEX BARRIER SURG. DRAPES & GOWNS
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KKX
1982-10-08
INSTA-HOLD
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KKX
1982-07-22
BARRIER ANTIMICROBIAL INCISE DRAPE
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KKX
1982-06-02
SURGIKOS INCISE DRAPE
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KKX
1982-05-12
CURITY PREMIUM CYSTOSCOPY TRAY
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KKX
1982-04-29
BOUNDARY SINGLE-USE CRANIOTOMY SHEET
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KKX
1982-03-18
DERMAFILE (CAT. # 38
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KKX
1982-03-10
ANAGO STERILE PRODUCTS; STOCKINETTES
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KKX
1982-02-04
DRAPE, SURGICAL
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KKX
1982-01-22
BOUNDARY SINGLE-USE DRAPES
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KKX
1982-01-18
SHEETS
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KKX
1981-12-18
BOUNDARY DRAPE TAPE
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KKX
1981-11-20
BOUNDARY SURGICAL DRAPE
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KKX
1981-11-16
BOUNDARY PROCESS CHANGE
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KKX
1981-11-06
STERILE ADHERENT DRAPES
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KKX
1981-10-02
UNI-THANE
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KKX
1981-09-17
3M GERMICIDAL SURGICAL INCISE DRAPE
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KKX
1981-08-20
BACTERICIDAL INCISE DRAPE
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KKX
1981-08-13
GATOR DRAPES
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KKX
1981-02-13
SOLVALINE
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KKX
1980-12-19
DISPOSABLE STERILE LAP SPONGE
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KKX
1980-12-17
O.R. DRAPES
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KKX
1980-12-17
METALLINE DRESSINGS
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KKX
1980-11-12
BOUNDARY SURGICAL DRAPES WITH ADHESIVE
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KKX
1980-11-12
DISPOSABLE SURGICAL DRAPE
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KKX
1980-10-31
DISP. FENESTRATED SURG. DRAPE SHEETS
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KKX
1980-10-31
COMFORT CUSHION DRY BURN PADS, STERILE
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KKX
1980-10-10
WHITE KNIGHT DRAPE SEAL
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KKX
1980-10-10
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
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KKX
1980-09-26
BOUNDARY SINGLE-USE DRAPES
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KKX
1980-09-26
BOUNDARY SINGLE-USE DRAPES
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KKX
1980-09-26
BOUNDARY SINGLE-USE DRAPE
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KKX
1980-09-16
TACKMER INCISE DRAPE
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KKX
1980-09-16
LAP SPONGES CAT.#801-850
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KKX
1980-08-20
BARRIER APERTURED DRAPE
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KKX
1980-08-20
BARRIER TOWEL DRAPE
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KKX
1980-05-20
BOUNDARY EXTREMITY DRAPE
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KKX
1980-05-20
STERILE ABDOMINAL PAD
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KKX
1980-05-20
STERILE DRAPE 17X18 W/3 FENESTRATION
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KKX
1980-05-20
STERILE DRAPE 17X18 CODE D-6A
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KKX
1980-05-20
WHITE KNIGHT SUPPLEMENTAL DRAPE
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KKX
1980-05-02
SHIELD DISP. REINFORCED DRAPE SHEETS
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KKX
1980-05-02
MEDSPEC SAFETY PINS
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KKX
1980-03-20
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
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KKX
1980-03-12
STERILE DRESSING PACK
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KKX
1980-01-11
STERILIZATION PROCESS/ABSORBENT TOWEL
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KKX
1980-01-11
STERILIZATION PROCESS CHANGE BOUNDARY
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KKX
1979-12-18
STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
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KKX
1979-12-10
DRAPE, MICROSCOPE
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KKX
1979-10-17
INSTRUMENT PAD
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KKX
1979-10-04
BARRIER & FACE MASK WITH INNER FACING
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KKX
1979-08-28
BARRIER *450* TAPE STRIP
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KKX
1979-08-28
FABRIC 450* TOWEL DRAPE
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KKX
1979-08-28
BARRIER* X-RAY CASSETTE DRAPE
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KKX
1979-08-28
BARRIER* OVERHEAD TABLE DRAPE
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KKX
1979-08-28
BARRIER* C-ARM DRAPE
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KKX
1979-07-11
SURG-O-PAK, GOWNS, SHEETS, AND TOWELS
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KKX
1979-07-03
SURGICAL FACE MASK
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KKX
1979-06-20
ACCU-SORB STERILE STOCKINETTES
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KKX
1979-06-15
CARDIAC CATHETERIZATION SHEETS/PACKS
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KKX
1979-06-05
KIMLON IMPERVIOUS STOCKINETTES
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KKX
1979-05-11
BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE*
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KKX
1979-05-08
KIMLON UNIVERSAL DRAPE
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KKX
1979-05-04
TREATED BARRIER INCISE DRAPE
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KKX
1979-04-10
IMPERVIOUS STERILE STOCKINETTE
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KKX
1979-04-04
DELTA-NET
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KKX
1979-03-21
DRAPES, DISPOSABLE SURGICAL
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KKX
1979-02-22
DRAPE PACKS, SURGICAL GOWNS
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