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510(k) Data Aggregation

    K Number
    K180217
    Device Name
    VESTEX Apparel
    Date Cleared
    2018-05-18

    (113 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VESTEX® Apparel ("VESTEX"), scrub tops, pants, skirts, and lab coats are apparel that provides fluid repellency and reduces the retention of Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel. The ability of VESTEX to reduce the retention of MRSA on the fabric surface has not been shown to correlate with the reduction of infections. Clinical studies to evaluate reduction in infection have not been performed for this device. VESTEX Apparel is not intended to replace personal protective equipment.
    Device Description
    VESTEX® Apparel is nonsterile, reusable, fluid repellant apparel containing an antimicrobial agent that is designed for continuous wear to provide protection to healthcare workers where intermittent or unexpected exposure to microorganisms from blood, body fluids and other potentially infectious material (OPIM) can occur. VESTEX® does not replace PPE worn for specific use and during episodes of expected blood, body fluid and other potentially infectious material (OPIM) exposure. VESTEX® has a dual mechanism of action that is fluid repellant and an antimicrobial agent. VESTEX® has a proprietary application method used to covalently bond a fluid repellent and an antimicrobial agent to the outer surface of the fabric. The primary mechanism of action is a fluid repellant fabric surface which acts to resist bacteria acquisition on the fabric. As the fluids and pathogens are repelled, the numbers of microorganisms that remain on the fabric are significantly reduced. The secondary mechanism of action is an antimicrobial agent. It has one of several possible modes of action, including disruption of the cell membrane, denaturation of cell surface and transmembrane proteins, and inactivation of bio-energetic systems to prevent the microorganisms from being retained on the fabric. This secondary mechanism of action reduces Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel.
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