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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 / June 2026 / K260806

510(k) cleared

Nitrile Disposable Examination Gloves

Vista Industries,, LLC · Jun 3, 2026 · K260806

FDA cleared the Nitrile Disposable Examination Gloves from Vista Industries,, LLC on Jun 3, 2026 under K260806, 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 Mar 12, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Vista Industries,, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260806?

K260806 is the FDA 510(k) for Nitrile Disposable Examination Gloves, submitted by Vista Industries,, LLC. FDA's decision date was Jun 3, 2026, under product code LZA (Polymer Patient Examination Glove).

Who makes the Nitrile Disposable Examination Gloves?

Vista Industries,, LLC, based in Los Angeles, CA, is the applicant of record for K260806.

How long did the K260806 review take?

FDA received the submission on Mar 12, 2026 and issued its decision on Jun 3, 2026, 83 days later.

← All decisions in June 2026