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510(k) Data Aggregation

    K Number
    K203534
    Device Name
    Surgical face mask (Model: Flat Ear Loop/CN102)
    Date Cleared
    2021-07-21

    (231 days)

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

    Crown Name Disposable Hygiene Products Fty., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgical face mask(Model: Flat Ear Loop/CN102) are intended to be worn to protect both the patient and healtheare 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 surgical face mask is pleated three-layer mask. The inner and outer layers are made of spun-bond polypropylene. The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue15:3 /CAS number:147-14-8), which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the surgical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the surgical face mask is in the middle layer of surgical face mask to allow the user to fit the surgical face mask around their noses, which is made of malleable aluminum wire coated with polypropylene resin.All of the material used in the construction of the new masks are being used in currently marketed devices. The dimensions of each surgical face mask are length 175±10 mm and width 90±10 mm,The dimensions of nose piece is length 110±10 mm, and the ear loop is length 180±20 mm. The surgical face mask are sold non-sterile and are intended to be single use,disposable devices.
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