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 K903439
Device Name DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL
Applicant
Glovco Malaysia Sdn Bhd
C/O Carl Parker Associates Inc
175n Commerce Dr., P.O. Box 12084
Hauppauge,  NY  11788
Applicant Contact CARL PARKER
Correspondent
Glovco Malaysia Sdn Bhd
C/O Carl Parker Associates Inc
175n Commerce Dr., P.O. Box 12084
Hauppauge,  NY  11788
Correspondent Contact CARL PARKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/23/1990
Decision Date 01/14/1991
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
-
-