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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 K101811
Device Name PROTEGRITY SMT LATEX SURGICALGLOVES
Applicant
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  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 Received06/29/2010
Decision Date 10/15/2010
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
Predetermined Change
Control Plan Authorized		 No
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