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 K021396
Device Name DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Applicant Contact V. NADARAJAN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Correspondent Contact V. NADARAJAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/02/2002
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-