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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 K122696
Device Name POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact TATYANA BOGDAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/04/2012
Decision Date 01/31/2013
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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