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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252313

510(k) cleared

Cardinal Health Nitrile Examination Gloves Extended Cuff

Cardinalhealth · Jan 14, 2026 · K252313

FDA cleared the Cardinal Health Nitrile Examination Gloves Extended Cuff from Cardinalhealth on Jan 14, 2026 under K252313, a traditional 510(k). The device falls under product code LZC, Medical Glove, Specialty, regulated at 21 CFR 880.6250 as a Class 1 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 25, 2025. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Cardinalhealth in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252313?

K252313 is the FDA 510(k) for Cardinal Health Nitrile Examination Gloves Extended Cuff, submitted by Cardinalhealth. FDA's decision date was Jan 14, 2026, under product code LZC (Medical Glove, Specialty).

Who makes the Cardinal Health Nitrile Examination Gloves Extended Cuff?

Cardinalhealth, based in Waukegan, IL, is the applicant of record for K252313.

How long did the K252313 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Jan 14, 2026, 173 days later.

← All decisions in January 2026