• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name polymer patient examination glove
510(k) Number K121549
Device Name NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Original Applicant
SIAM SEMPERMED CORP. LTD.
13900 49th street north
clearwater,  FL  33762
Original Contact william e harris
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/25/2012
Decision Date 12/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-