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510(k) Data Aggregation

    K Number
    K252167

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (162 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enhanced silver gelling fiber dressing (OTC) may be used for the management of:

    • Abrasions
    • Lacerations;
    • Minor cuts;
    • Minor scalds and burns.

    Extra enhanced silver gelling fiber dressing (Rx only) may be used for the management of:

    • Partial thickness (superficial second degree) burns;
    • Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
    • Surgical wounds left to heal by secondary intention such as dehisced surgical incisions;
    • Surgical wounds that heal by primary intent such as dermatological and surgical incisions(e.g., orthopedic and vascular);
    • Traumatic wounds;
    • Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
    Device Description

    Enhanced silver gelling fiber dressing (OTC)/Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a soft, conformable, sterile dressing composed of sodium carboxymethyl cellulose fibers, strengthening layer (polyester), 1.2% (w/w) ionic silver, and stitched with enhance fibers (polyester). This conformable dressing absorbs wound fluid and creates a soft gel, provides a moist wound healing environment, and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days.

    AI/ML Overview

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