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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 / K253824

510(k) cleared

Powder Free Nitrile Examination Gloves Non-Sterile Black

Kanglongda Vietnam Protection Technology Company Limited · Jun 18, 2026 · K253824

FDA cleared the Powder Free Nitrile Examination Gloves Non-Sterile Black from Kanglongda Vietnam Protection Technology Company Limited on Jun 18, 2026 under K253824, 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 Dec 1, 2025. The decision came 199 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 Kanglongda Vietnam Protection Technology Company Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253824?

K253824 is the FDA 510(k) for Powder Free Nitrile Examination Gloves Non-Sterile Black, submitted by Kanglongda Vietnam Protection Technology Company Limited. FDA's decision date was Jun 18, 2026, under product code LZA (Polymer Patient Examination Glove).

Who makes the Powder Free Nitrile Examination Gloves Non-Sterile Black?

Kanglongda Vietnam Protection Technology Company Limited, based in Hue City, is the applicant of record for K253824.

How long did the K253824 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Jun 18, 2026, 199 days later.

← All decisions in June 2026