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 latex patient examination glove
510(k) Number K162175
Device Name Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Applicant
Viet Glove Corporation
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District
Bau Bang Province,  VN
Applicant Contact PHAM NGOC THANH
Correspondent
Viet Glove Corporation
Cau Sat Hamlet, Lai Hung Commune
Ben Cat District
Bau Bang Province,  VN
Correspondent Contact TERENCE LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/03/2016
Decision Date 11/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-