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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 K122727
Device Name BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
70 SIR JOHN ROGERSONS QUAY
DUBLIN 2,  IE
Applicant Contact MICHAEL RIORDAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/05/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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