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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K160411
Device Name Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
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 Number880.6250
Classification Product Code
LYZ  
Date Received02/16/2016
Decision Date 07/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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