FDA cleared the Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate from Cardinalhealth on Sep 2, 2026 under K261749, a traditional 510(k). The review panel was Unknown.
FDA logged the submission as received on May 28, 2026. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Cardinalhealth has one other decision in the tracker over the last 12 months: K252313 (Cardinal Health Nitrile Examination Gloves Extended Cuff).
Questions & Answers
What did FDA clear under K261749?
K261749 is the FDA 510(k) for Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, submitted by Cardinalhealth. FDA's decision date was Sep 2, 2026.
Who makes the Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?
Cardinalhealth, based in Waukegan, IL, is the applicant of record for K261749.
How long did the K261749 review take?
FDA received the submission on May 28, 2026 and issued its decision on Sep 2, 2026, 97 days later.