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510(k) Data Aggregation

    K Number
    K151185
    Device Name
    AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
    Manufacturer
    ABL Medical, LLC
    Date Cleared
    2016-02-05

    (277 days)

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

    ABL Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use -For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use -To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.
    Device Description
    AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are cleansing solutions intended for the external cleansing of skin and wounds. The mechanical action of the fluid moving across the skin or wound surface provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser and the AGX Wound Wash Skin and Wound Cleanser are identical devices. The only difference is that the AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is for prescription use and the AGX Wound Wash Skin and Wound Cleanser is for Over-the-Counter Use. The solution consists of deionized water containing 10ppm silver. The silver is from American Biotech Labs and is the same silver used in ABL Medical's Wound Dressing hydrogel devices cleared in K140483, K092826 and K082333. The silver acts as a preservative that may help inhibit the growth of microorganisms within the solution while in storage which was established through testing in accordance with USP <51> and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae. MRSA, VRE, as well as fungi such as Candida albicans and aspergillus niger.
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    K Number
    K140483
    Device Name
    ASAP OTC WOUND DRESSING GEL
    Manufacturer
    ABL MEDICAL, LLC
    Date Cleared
    2014-05-20

    (83 days)

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

    ABL MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
    Device Description
    ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP OTC™ Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a popopen screw cap on the other end).
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