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 K992679
Device Name SURGEON POWDER-FREE GLOVES, LATEX, STERILE
Applicant
Wear Safe Malaysia Sdn. Bhd.
Lot 1, Leboh Hishamuddin Satu,
North Klang Straits Ind. Area
Port Klang, Selangor, D.E.,  MY 42000
Applicant Contact CLAUDE COTTET
Correspondent
Wear Safe Malaysia Sdn. Bhd.
Lot 1, Leboh Hishamuddin Satu,
North Klang Straits Ind. Area
Port Klang, Selangor, D.E.,  MY 42000
Correspondent Contact CLAUDE COTTET
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/10/1999
Decision Date 10/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-