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
2023-10-25
KKX
2023-05-18
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
View details →
KKX
2021-07-30
BeneHold Surgical Incise Drape with CHG antimicrobial
View details →
KKX
2020-04-26
ControlRad Sterile Cover
View details →
KKX
2017-09-14
MediClear PreOp
View details →
KKX
2013-07-05
TIBURON SURGICAL DRAPE
View details →
KKX
2013-06-06
DAS MEDICAL EQUIPMENT DRAPES
View details →
KKX
2013-02-14
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
View details →
KKX
2012-12-12
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
View details →
KKX
2012-05-08
COBES SURGICAL DRAPE
View details →
KKX
2011-12-01
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
View details →
KKX
2011-09-29
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
View details →
KKX
2011-01-13
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
View details →
KKX
2011-01-04
RADSCAN EQUIPMENT SLICKER
View details →
KKX
2010-11-19
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
View details →
KKX
2010-11-09
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
View details →
KKX
2010-10-05
IMC SURGICAL DRAPE
View details →
KKX
2010-10-04
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
View details →
KKX
2010-09-20
EMM EQUIPMENT COVER-POLYTHYLENE
View details →
KKX
2010-09-20
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
View details →
KKX
2010-05-06
BUSSE SURGICAL DRAPES IV
View details →
KKX
2010-04-20
IMC SURGICAL DRAPE
View details →
KKX
2009-10-09
BUSSE SURGICAL DRAPES III
View details →
KKX
2009-09-22
MRI NEURO DRAPE
View details →
KKX
2009-03-25
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
View details →
KKX
2009-03-06
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
View details →
KKX
2009-02-26
BUSSE SURGICAL DRAPE
View details →
KKX
2008-12-09
BUSSE SURGICAL DRAPE
View details →
KKX
2008-11-17
SRI LP DRAPE
View details →
KKX
2008-10-20
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
View details →
KKX
2008-08-08
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
View details →
KKX
2008-07-21
ENDODRAPE(TM)
View details →
KKX
2007-10-10
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
View details →
KKX
2007-09-24
GENERAL SURGERY DRAPES
View details →
KKX
2007-07-30
ENDODRAPE
View details →
KKX
2007-03-05
JOYKEY SURGICAL DRAPES (STERILE)
View details →
KKX
2006-09-25
SURGICAL DRAPES
View details →
KKX
2006-08-01
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
View details →
KKX
2006-07-24
OR SPECIFIC BIG CASE BACK TABLE COVER
View details →
KKX
2006-05-31
MICROTEK MEDICAL WARMING DRAPE
View details →
KKX
2006-03-16
EQUIPMENT SLUSH DRAPE
View details →
KKX
2006-02-15
GORE-TEX NON-STERILE SURGICAL GOWNS
View details →
KKX
2005-12-01
STERILE EQUIPMENT COVERS
View details →
KKX
2005-11-17
IMC SURGICAL DRAPES
View details →
KKX
2005-08-15
3L SURGICAL DRAPES
View details →
KKX
2005-07-14
BARRIER SURGICAL DRAPES
View details →
KKX
2005-06-07
IMC DRAPES
View details →
KKX
2005-05-17
MICROTEK EQUIPMENT DRAPES
View details →
KKX
2005-05-10
LASIK EYE DRAPE
View details →
KKX
2005-04-27
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
View details →
KKX
2005-04-25
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
View details →
KKX
2005-03-16
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
View details →
KKX
2005-03-11
UNDER BUTTOCKS DRAPE
View details →
KKX
2005-02-03
FOOTHILLS SURGICAL DRAPES
View details →
KKX
2004-12-10
PROMEDICAL SURGICAL DRAPES
View details →
KKX
2004-10-05
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
View details →
KKX
2004-08-26
SABRESOURCE DRAPE
View details →
KKX
2004-06-25
IMALUX OCT PROBE GUIDE
View details →
KKX
2003-09-22
ALEXIS WOUND RETRACTOR
View details →
KKX
2003-09-10
STERI-DRAPE SURGICAL DRAPES
View details →
KKX
2003-08-11
DEROYAL SURGICAL DRAPES BACKTABLE COVER
View details →
KKX
2003-06-10
KLINIDRAPE SURGICAL DRAPES
View details →
KKX
2003-05-30
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
View details →
KKX
2003-04-29
DEROYAL DRAPES, STERILE, NON-STERILE
View details →
KKX
2003-02-11
TRILAMINATE DRAPES/TIBURON
View details →
KKX
2002-11-08
PRIMAGARD SURGICAL GOWNS
View details →
KKX
2002-11-08
PRIMAGARD SURGICAL EQUIPMENT DRAPES
View details →
KKX
2002-11-06
DRAPES WITH ABSORBENT REINFORCEMENT
View details →
KKX
2002-11-04
MEDLINE ASEP PLUS SURGICAL DRAPES
View details →
KKX
2002-09-23
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
View details →
KKX
2002-09-18
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
View details →
KKX
2002-08-19
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
View details →
KKX
2002-05-03
MASTER & FRANK SURGICAL DRAPES (STERILE)
View details →
KKX
2002-04-15
WOUND PROTECTOR/RETRACTOR
View details →
KKX
2002-03-06
TOWEL DRAPE, MODELS 4409, 4410
View details →
KKX
2001-10-15
MERTEX-PLUS REUSABLE SURGICAL DRAPE
View details →
KKX
2001-10-11
MODIFICATION TO: COMPEL SURGICAL DRAPES
View details →
KKX
2001-09-18
ADVANCE MEDICAL DESIGNS FLUID POUCH
View details →
KKX
2001-07-10
SURGICAL DRAPES
View details →
KKX
2001-05-22
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
View details →
KKX
2001-04-24
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
View details →
KKX
2001-03-12
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE
View details →
KKX
2001-01-26
PATIENT DRAPE, SURGICAL
View details →
KKX
2000-12-08
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
View details →
KKX
2000-10-26
NEUROTOLOGY DRAPE, MODEL TBD
View details →
KKX
2000-09-01
EQUIPMENT DRAPES
View details →
KKX
2000-08-17
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
View details →
KKX
2000-08-15
SURGICAL DRAPES
View details →
KKX
2000-08-04
EEI SLUSH PAN DRAPE
View details →
KKX
2000-06-23
RESOLVE SURGICAL O.R. TOWELS
View details →
KKX
2000-06-23
KLINIDRAPE SURGICAL DRAPES
View details →
KKX
2000-06-09
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
View details →
KKX
2000-03-17
CONVERTORS EQUIPMENT DRAPES
View details →
KKX
2000-02-04
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
View details →
KKX
2000-01-12
CONVERTORS SURGICAL DRAPES
View details →
KKX
1999-09-27
BROADLINE OR TOWELS
View details →
KKX
1999-09-24
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
View details →
KKX
1999-06-23
HAL SCOPE HOLDER SYSTEM
View details →
KKX
1998-08-11
OPERATING ROOM TOWELS
View details →
KKX
1998-07-10
CONVERTORS TRILAMINATE DRAPES
View details →No matching devices.
Advertisement