• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name surgeon's gloves
510(k) Number K121335
Device Name G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
Original Applicant
HUTCHINSON SANTE S.N.C.
rue marret paturel
liancourt,  FR f-60140
Original Contact raffi krikorian
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/03/2012
Decision Date 09/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-