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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 K121529
Device Name BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
hamilton house, 10 queen st
hamilton, bermuda, 
Contact wesley toavs
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/24/2012
Decision Date 07/12/2012
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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