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THE TAPE

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 / May 2026 / K253060

510(k) cleared

Sterile Latex Powder Free Surgical Gloves

Protect Gloves Company Limited · May 22, 2026 · K253060

FDA cleared the Sterile Latex Powder Free Surgical Gloves from Protect Gloves Company Limited on May 22, 2026 under K253060, a traditional 510(k). The device falls under product code KGO, Surgeon'S Gloves, regulated at 21 CFR 878.4460 as a Class 1 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 22, 2025. The decision came 242 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 Protect Gloves Company Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253060?

K253060 is the FDA 510(k) for Sterile Latex Powder Free Surgical Gloves, submitted by Protect Gloves Company Limited. FDA's decision date was May 22, 2026, under product code KGO (Surgeon'S Gloves).

Who makes the Sterile Latex Powder Free Surgical Gloves?

Protect Gloves Company Limited, based in Rayong, is the applicant of record for K253060.

How long did the K253060 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on May 22, 2026, 242 days later.

← All decisions in May 2026