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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 / April 2026 / K260860

510(k) cleared

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

Basic Medical Technology, Inc. · Apr 7, 2026 · K260860

FDA cleared the Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) from Basic Medical Technology, Inc. on Apr 7, 2026 under K260860, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LYZ, Vinyl 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 Mar 16, 2026. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

Basic Medical Technology, Inc. has one other decision in the tracker over the last 12 months: K253160 (Syntex Exam Gloves).

Questions & Answers

What did FDA clear under K260860?

K260860 is the FDA 510(k) for Powder Free Synthetic Vinyl Exam Gloves (Blue, Black), submitted by Basic Medical Technology, Inc.. FDA's decision date was Apr 7, 2026, under product code LYZ (Vinyl Patient Examination Glove).

Who makes the Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)?

Basic Medical Technology, Inc., based in Ontario, CA, is the applicant of record for K260860.

How long did the K260860 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Apr 7, 2026, 22 days later.

← All decisions in April 2026

Sources