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The Tracker / September 2026 / K254246

510(k) cleared

LT Antibacterial Foam with Silver Dressing

Zhejiang Longterm Medical Technology Co., Ltd. · Sep 10, 2026 · K254246

FDA cleared the LT Antibacterial Foam with Silver Dressing from Zhejiang Longterm Medical Technology Co., Ltd. on Sep 10, 2026 under K254246, a traditional 510(k). The device falls under product code NAD, Dressing, Wound, Occlusive, regulated at 21 CFR 878.4020 as a Class 1 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 29, 2025. The decision came 255 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 Zhejiang Longterm Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254246?

K254246 is the FDA 510(k) for LT Antibacterial Foam with Silver Dressing, submitted by Zhejiang Longterm Medical Technology Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code NAD (Dressing, Wound, Occlusive).

Who makes the LT Antibacterial Foam with Silver Dressing?

Zhejiang Longterm Medical Technology Co., Ltd., based in Deqing, is the applicant of record for K254246.

How long did the K254246 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 10, 2026, 255 days later.

← All decisions in September 2026