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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 K121464
Device Name BLUE POWER FREE NITRILE EXAMINATION GLOVE
Original Applicant
NORTHSTAR HEALTHCARE HOLDINGS
70 sir john rogersons quay
dublin 2,  IE
Original Contact michael riordan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/17/2012
Decision Date 07/05/2012
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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