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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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,  EI hm11
Original Contact wesley toavs
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/21/2012
Decision Date 07/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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