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 K000971
Device Name PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
Applicant
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3,
Kawasan Perusahaan Bandar Baru
Salak Tinggi, Sepang Selangor,  MY 43900
Applicant Contact YUE WAH CHOW
Correspondent
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3,
Kawasan Perusahaan Bandar Baru
Salak Tinggi, Sepang Selangor,  MY 43900
Correspondent Contact YUE WAH CHOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/27/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-