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510(k) Data Aggregation

    K Number
    K230093
    Device Name
    Disposable 4 Layers Surgical Face Mask
    Date Cleared
    2023-03-02

    (49 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Social Medical Supply LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.
    Device Description
    The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.
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