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510(k) Data Aggregation

    K Number
    K211833
    Device Name
    Disposable Medical Face Mask
    Date Cleared
    2022-01-16

    (216 days)

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

    Zhejiang The Purples Protective Products Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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 disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm. The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
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