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 Surgeon'S Gloves
510(k) Number K994081
Device Name SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
Applicant
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact EUGENE V GOORCHENKO
Correspondent
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact EUGENE V GOORCHENKO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/03/1999
Decision Date 01/18/2000
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
Predetermined Change
Control Plan Authorized		 No
-
-