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510(k) Data Aggregation

    K Number
    K210761
    Device Name
    Velguard Surgical Face Mask
    Date Cleared
    2021-07-16

    (123 days)

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

    Esstee Exports Health Care Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Velguard Surgical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. 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 nonsterile.
    Device Description
    The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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