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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 K113707
Device Name STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
Applicant
Cardinal Health-Medical Products and Services
1430 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 Received12/16/2011
Decision Date 04/27/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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