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 K014230
Device Name STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Applicant
Supermax Glove Manufacturing Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Buloh, Selangor,  MY 47000
Applicant Contact STANLEY THAI
Correspondent
Supermax Glove Manufacturing Sdn Bhd
Lot 42, Putra Industrial Park
Bukit Rahman Putra
Sungai Buloh, Selangor,  MY 47000
Correspondent Contact STANLEY THAI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/26/2001
Decision Date 03/13/2002
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
-
-