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THE TAPE

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 / October 2025 / K252075

510(k) cleared

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Program Insite, LLC · Oct 17, 2025 · K252075

FDA cleared the Program insite® Powder-Free, Disposable Nitrile Exam Gloves from Program Insite, LLC on Oct 17, 2025 under K252075, a abbreviated 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 Jul 2, 2025. The decision came 107 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 Program Insite, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252075?

K252075 is the FDA 510(k) for Program insite® Powder-Free, Disposable Nitrile Exam Gloves, submitted by Program Insite, LLC. FDA's decision date was Oct 17, 2025, under product code LZA (Polymer Patient Examination Glove).

Who makes the Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

Program Insite, LLC, based in Olney, MD, is the applicant of record for K252075.

How long did the K252075 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Oct 17, 2025, 107 days later.

← All decisions in October 2025