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510(k) Data Aggregation

    K Number
    K053476
    Device Name
    ALLWOUND
    Manufacturer
    Date Cleared
    2006-06-26

    (194 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AT SQUARED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WoundPal is intended to be used as a primary dressing in the management of partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations.
    Device Description
    The proposed WoundPal is a single use wound dressing consisting of a woven cotton gauze treated with an OTC antibiotic mixture composed of Polymyxin B Sulfate USP (10,000 units/gram) and Bacitracin Zinc USP (500 units/gram) in a hydrogel with 2% w/w lidocaine hydrochloride. Normal saline 0.9% is also added to maintain a moist dressing. A trace amount of oil of wintergreen is added as a fragrance. The product is intended as a primary dressing for use in the local management of painful skin wounds. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. The dressing may be held in place with a variety of secondary dressings, including an additional bandage or with the addition of an outer layer comprised of a polymeric film that may be secured by applying zinc oxide ointment USP between the film and intact skin surrounding the wound.
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