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 K964724
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Pwa Industries Sdn. Bhd.
Batu 15 1/2 Sungai Pelong
47000, Sungai Buloh
Selangor Darul Ehsan,  MY 47000
Applicant Contact AZMAN ISMAIL
Correspondent
Pwa Industries Sdn. Bhd.
Batu 15 1/2 Sungai Pelong
47000, Sungai Buloh
Selangor Darul Ehsan,  MY 47000
Correspondent Contact AZMAN ISMAIL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/15/1996
Decision Date 06/16/1997
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
Predetermined Change
Control Plan Authorized		 No
-
-