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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K252313
Device Name Cardinal Health Nitrile Examination Gloves Extended Cuff
Applicant
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Vani Bala
Correspondent
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Vani Bala
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
LZA   OPJ   QDO  
Date Received07/25/2025
Decision Date 01/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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