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510(k) Data Aggregation

    K Number
    K200923
    Device Name
    Single-use Surgical Mask
    Manufacturer
    BYD Precision Manufacturer Co.Ltd.
    Date Cleared
    2020-08-26

    (141 days)

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

    BYD Precision Manufacturer Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use Surgical Masks (Model:FE2311) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face 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 device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The proposed device(s) 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 model of proposed device, ear loops, is 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 contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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