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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 / October 2025 / K252467

510(k) cleared

Disposable Vinyl Examination Gloves

Viet Phu Trade and Import Export Co., Ltd. · Oct 27, 2025 · K252467

FDA cleared the Disposable Vinyl Examination Gloves from Viet Phu Trade and Import Export Co., Ltd. on Oct 27, 2025 under K252467, a traditional 510(k). 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 Aug 6, 2025. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Viet Phu Trade and Import Export Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252467?

K252467 is the FDA 510(k) for Disposable Vinyl Examination Gloves, submitted by Viet Phu Trade and Import Export Co., Ltd.. FDA's decision date was Oct 27, 2025, under product code LYZ (Vinyl Patient Examination Glove).

Who makes the Disposable Vinyl Examination Gloves?

Viet Phu Trade and Import Export Co., Ltd., based in Dong Trieu, is the applicant of record for K252467.

How long did the K252467 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Oct 27, 2025, 82 days later.

← All decisions in October 2025