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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name latex patient examination glove
510(K) Number K122788
Device Name TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
70 sir john rogersons quay
dublin 2, 
Contact michael riordan
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/11/2012
Decision Date 01/17/2013
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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