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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 K121947
Device Name ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
HAMILTON HOUSE, 10 QUEEN ST
HAMILTON, BERMUDA,  IE HM11
Applicant Contact WESLEY TOAVS
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/03/2012
Decision Date 09/10/2012
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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