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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name patient examination glove, specialty
510(k) Number K121926
Device Name BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
Original Applicant
NORTHSTAR HEALTHCARE HOLDINGS
hamilton house, 10 queen st
hamilton, bermuda,  IE hm11
Original Contact wesley toavs
Regulation Number880.6250
Classification Product Code
LZC  
Date Received07/02/2012
Decision Date 09/20/2012
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
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