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510(k) Data Aggregation

    K Number
    K955453
    Device Name
    ACTICOAT SILVER COATED DRESSING
    Manufacturer
    WESTAIM TECHNOLOGIES, INC.
    Date Cleared
    1996-05-31

    (184 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.
    Device Description
    Acticoat™ silver coated dressing is a 3-ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver coated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.
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