Product code KKX

Current FDA Classification

Device name
Drape, Surgical
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4370
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.2023-10-25
K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company2023-05-18
K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba2021-07-30
K200238ControlRad Sterile CoverControlrad, Inc.2020-04-26
K163556MediClear PreOpCovalontechnologies, Inc.2017-09-14
K133080Plus Surgical Drapes (EO Sterilized), PMDB-XXXFoshan Nanhai Plus Medical Co, Ltd.2015-06-24
K141324HONGYU DISPOSABLE SURGICAL DRAPESWeihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
K140195SURGICAL DRAPEGriffith-Lucas, LLC2014-09-10
K1403303M STERI-DRAPE FABRIC SURGICAL DRAPES3M Healthcare2014-08-18
K141438WHITNEY MEDICAL SOLUTIONS ESHIELDWhitney Medical Solutions2014-08-14
K1402503M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE3M Healthcare2014-07-25
K140064SURGISLEEVE WOUND PROTECTORCovidien2014-03-12
K131571AVD RIGHT RADIAL DRAPEAdvanced Vascular Dynamics2014-01-31
K130404TIBURON SURGICAL DRAPECardinal Health200, LLC2013-07-05
K121436DAS MEDICAL EQUIPMENT DRAPESDas Medical, LLC2013-06-06
K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IVExact Medical Manufacturing, Inc.2013-02-14
K122000HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVERChangzhou Holymed Products Co., Ltd.2012-12-12
K112378COBES SURGICAL DRAPECobes Industries Co., Ltd.2012-05-08
K111458GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERSGri Medical & Electronic Technology Co., Ltd.2011-12-01
K112136TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPEKunshan Jiehong Nonwoven Product Co., Ltd.2011-09-29
K102861SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)A Plus International, Inc.2011-01-13
K101350RADSCAN EQUIPMENT SLICKERRadscan Medical Equipment, Inc.2011-01-04
K094016NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, HHinson and Hale Medical Technologies, Inc.2010-11-19
K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKimberly-Clark Corp.2010-11-09
K100991IMC SURGICAL DRAPEInternational Medsurg Connection2010-10-05
K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)Exact Medical Manufacturing, Inc.2010-10-04
K101689EMM EQUIPMENT COVER-POLYTHYLENEExact Medical Manufacturing, Inc.2010-09-20
K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004Exact Medical Manufacturing, Inc.2010-09-20
K093909BUSSE SURGICAL DRAPES IVBusse Hospital Disposables, Inc.2010-05-06
K100208IMC SURGICAL DRAPEInternational Medsurg Connection2010-04-20

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