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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K261749
Device Name Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Vani Bala
Correspondent
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Vani Bala
Date Received05/28/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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