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StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / September 2026 / K261749

510(k) cleared

Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Cardinalhealth · Sep 2, 2026 · K261749

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 device falls under product code LZA, Polymer Patient Examination Glove, regulated at 21 CFR 880.6250 as a Class 1 device. The review panel was General Hospital.

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, under product code LZA (Polymer Patient Examination Glove).

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.

← All decisions in September 2026

Sources