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510(k) K254246

LT Antibacterial Foam with Silver Dressing by Zhejiang Longterm Medical Technology Co., Ltd. — Product Code NAD

K254246 is an FDA 510(k) premarket notification submitted by Zhejiang Longterm Medical Technology Co., Ltd. for the device "LT Antibacterial Foam with Silver Dressing". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Zhejiang Longterm Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2026
Date Received
December 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Zhejiang Longterm Medical Technology Co., Ltd.

  • K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (May 31, 2022)
  • K202823 — Innomed NPWT Silicone Foam Dressing (December 15, 2021)
  • K192478 — LT Antibacterial Alginate with Silver Dressing (June 17, 2020)
  • K182458 — Longterm NPWT Foam Dressing Kit (May 23, 2019)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources