FDA.report

510(k) K222578

Device
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
Applicant
3M Company
510(k) number
K222578
Product code
KKX
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-18
Date received
2022-08-25
Regulation
878.4370
Classification name
Drape, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Hilary Hovde
Address
2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code KKX

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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