LT Antibacterial Foam with Silver Dressing
FDA 510(k) K254246 · Zhejiang Longterm Medical Technology Co., Ltd.
510(k) numberK254246
Submission
- Device name
- LT Antibacterial Foam with Silver Dressing
- Applicant
- Zhejiang Longterm Medical Technology Co., Ltd.
Deqing, CN - Received
- December 29, 2025
- Decision date
- September 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
| K964534 | Otosilk Otological Graft DressingNAD · Traditional | Boston Medical Products, Inc. | 04/09/1997SE |
More from Boston Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitOMP · Traditional | 05/31/2022SE |
| K202823 | Innomed NPWT Silicone Foam DressingOMP · Traditional | 12/15/2021SE |
| K192478 | LT Antibacterial Alginate with Silver DressingFRO · Traditional | 06/17/2020SE |
| K182458 | Longterm NPWT Foam Dressing KitOMP · Traditional | 05/23/2019SE |
Questions and answers
When was LT Antibacterial Foam with Silver Dressing cleared by the FDA?
LT Antibacterial Foam with Silver Dressing (K254246) received a 510(k) decision of Substantially Equivalent on September 10, 2026, 255 days after the submission was received.
What is the product code of K254246?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.