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 Polymer Patient Examination Glove
510(k) Number K951921
Device Name SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
Applicant
Wembley Rubber Products (M) Sdn Bhd
Bandar Baru Salk Tinggi,
Sepang Selangor
Darul Ehsan,  MY
Applicant Contact ONG GHEE CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
Bandar Baru Salk Tinggi,
Sepang Selangor
Darul Ehsan,  MY
Correspondent Contact ONG GHEE CHEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/24/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-