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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 K121897
Device Name PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact TATYANA BOGDAN
Correspondent
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact TATYANA BOGDAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/29/2012
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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