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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(k) Number K120934
Device Name PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
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 Number878.4460
Classification Product Code
KGO  
Date Received03/28/2012
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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