FDA.reportPublic FDA data

510(k) K881479

Device
Operation Room Towel
Applicant
RAHN LABORATORIES
510(k) number
K881479
Product code
KKX
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-14
Date received
1988-04-07
Regulation
878.4370
Classification name
Drape, Surgical, Antimicrobial
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RANDAL J KIRK
Address
P.O. Box 126 Bland VA US 24315 24315

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KKX#

510(k), Device, Applicant table
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