LT Antibacterial Foam with Silver Dressing— 510(k) K254246
Substantially EquivalentZhejiang Longterm Medical Technology Co., Ltd.
FDA 510(k) clearance K254246 for LT Antibacterial Foam with Silver Dressing, Substantially Equivalent on 2026-09-10. Applicant: Zhejiang Longterm Medical Technology Co., Ltd.. Device class: 1.
Summary
LT Antibacterial Foam with Silver Dressing is a foam wound dressing containing silver, filed under NAD, occlusive wound dressings.
The record lists it as Class I under 21 CFR 878.4020, reviewed by the General and Plastic Surgery panel as a Traditional 510(k). Most Class I devices don't need a 510(k) at all. The silver and the antibacterial claim are the likely reason this one did, since they take the product beyond a plain occlusive dressing.
Zhejiang Longterm Medical Technology filed from Deqing, China. Review took 255 days (December 29, 2025 to September 10, 2026).
Clearance details
- Applicant
- Zhejiang Longterm Medical Technology Co., Ltd.
- Product code
- Code NAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deqing, CN
Recent devices under product code NAD
view allMore clearances from Zhejiang Longterm Medical Technology Co., Ltd.
view allAdverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.