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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 / January 2026 / K253160

510(k) cleared

Syntex Exam Gloves

Basic Medical Technology, Inc. · Jan 23, 2026 · K253160

FDA cleared the Syntex Exam Gloves from Basic Medical Technology, Inc. on Jan 23, 2026 under K253160, 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 Sep 26, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Basic Medical Technology, Inc. has one other decision in the tracker over the last 12 months: K260860 (Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)).

Questions & Answers

What did FDA clear under K253160?

K253160 is the FDA 510(k) for Syntex Exam Gloves, submitted by Basic Medical Technology, Inc.. FDA's decision date was Jan 23, 2026, under product code LZA (Polymer Patient Examination Glove).

Who makes the Syntex Exam Gloves?

Basic Medical Technology, Inc., based in Ontario, CA, is the applicant of record for K253160.

How long did the K253160 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jan 23, 2026, 119 days later.

← All decisions in January 2026

Sources