Cleared Traditional

K254246 - LT Antibacterial Foam with Silver Dressing

K254246 is an FDA 510(k) clearance for LT Antibacterial Foam with Silver Dressing, manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K254246 · Zhejiang Longterm Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
255d
Days
Class 1
Risk

K254246 is an FDA 510(k) clearance for the LT Antibacterial Foam with Silver Dressing. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Zhejiang Longterm Medical Technology Co., Ltd. (Deqing, CN). The FDA issued a Cleared decision on September 10, 2026 after a review of 255 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Longterm Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K254246

510(k) Number K254246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 10, 2026
Days to Decision 255 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 55
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