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510(k) Data Aggregation

    K Number
    K220067
    Device Name
    Medical Surgery Mask, Model:2626-7
    Date Cleared
    2022-08-30

    (232 days)

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

    Dongguan Missadola Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The medical surgery mask mask is intended to be worn to protect 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 medical surgery mask is pleated three-layer mask with ear loops and nose piece. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The medical surgery mask is 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 medical surgery mask.The inner layer is white. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgery mask is in the middle layer of medical surgery mask to allow the user to fit the medical surgery mask around their noses, which is made of malleable aluminum wire. The dimensions of each medical surgery mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm. The mask model 2626-7 meets level 3 performance requirements in ASTM F2100.The medical surgery masks are sold non-sterile and are intended to be single use,disposable devices.
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