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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 K153316
Device Name Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
Applicant
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Megan Middaugh
Correspondent
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact Megan Middaugh
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received11/17/2015
Decision Date 05/12/2016
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
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