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510(k) Data Aggregation

    K Number
    K210513
    Device Name
    UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
    Manufacturer
    Universal Incorporation
    Date Cleared
    2021-09-29

    (218 days)

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

    Universal Incorporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
    Device Description
    UNIWEB SURGICAL MASK are 3-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
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