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510(k) Data Aggregation

    K Number
    K210023
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-04-02

    (88 days)

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

    Guangdong Winsun Personal Care Products Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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(s), provided non-sterile.
    Device Description
    The proposed devices are three-layer, flat pleated masks. A Surgical Face Mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a steel wire with polyethylene covering. The proposed devices are provided non-sterile and are intended to be single use, disposable devices.
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