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 K971183
Device Name GOLD FINGERS
Applicant
Alliance Rubber Products Sdn. Bhd.
878, Jalan Bandar Baru, Sungei
Kecil, Nibong Tebal
Pulau Pinang,  MY 14300
Applicant Contact CHUA HOOI KOON
Correspondent
Alliance Rubber Products Sdn. Bhd.
878, Jalan Bandar Baru, Sungei
Kecil, Nibong Tebal
Pulau Pinang,  MY 14300
Correspondent Contact CHUA HOOI KOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/31/1997
Decision Date 08/08/1997
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
-
-