• 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 K121506
Device Name UTB BLUE POWDER FREE NITRILE
Original Applicant
NORTHSTAR HEALTHCARE HOLDINGS
hamilton house, 10 queen st
hamilton, bermuda,  IE hm11
Original Contact wesley toavs
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/21/2012
Decision Date 07/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-