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 K963771
Device Name CHLOROPRENE EXAM GLOVES
Applicant
P.T. Irama Dinamika Latex
Jl. Kapten Pattimura # 23/
235 Medan 21053
Indonesia,  ID
Applicant Contact ANIL TANELJA
Correspondent
P.T. Irama Dinamika Latex
Jl. Kapten Pattimura # 23/
235 Medan 21053
Indonesia,  ID
Correspondent Contact ANIL TANELJA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/19/1996
Decision Date 12/19/1996
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
-
-