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510(k) Data Aggregation

    K Number
    K992436
    Device Name
    GOWN BACK, MODEL 13-403N; 13-404N; 13-405N
    Manufacturer
    Date Cleared
    2000-01-20

    (182 days)

    Product Code
    Regulation Number
    878.4040
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    Applicant Name (Manufacturer) :

    TECHSTYLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Target population: Surgeons or other members of the surgical team. The Gown Back is to be worn over a surgeon's gown during procedures and in situation when the surgeon's back needs to be considered sterile. This accessory device is used to protect both operating room personnel and the surgical patient from the transfer of microorganisms, body fluids, and particulate matter.
    Device Description
    The device is a vest, commonly called a Gown Back, with a front snap opening. The Gown Back is fluid repellent; it is Single Use. The primary intended use for the Gown Back is as a sterile vest to be worn over a surgeon's gown during procedures or in situations when the surgeon's back needs to be considered sterile. It provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. The Gown Back is not a primary protective garment. The vest design does not provide complete coverage, and the fabric is fluid repellent, not a fluid barrier.
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