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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 K110272
Device Name STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
Applicant
Cardinal Health, Inc.
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact TATYANA BOGDAN
Correspondent
Cardinal Health, Inc.
1430 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact TATYANA BOGDAN
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received01/31/2011
Decision Date 06/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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