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510(k) Data Aggregation

    K Number
    K202903
    Device Name
    Surgical Face Mask
    Date Cleared
    2022-03-24

    (541 days)

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

    **Rizhao Sanqi Medical **& Health Articles Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
    Device Description
    The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
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