Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Polymer Patient Examination Glove
510(k) Number K131841
Device Name KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact CHRISTINE L MACAULEY
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact CHRISTINE L MACAULEY
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/21/2013
Decision Date 11/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-