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510(k) Data Aggregation

    K Number
    K202577
    Device Name
    Medical Surgical Mask-Model MP002-5, MP002-6
    Date Cleared
    2021-01-11

    (125 days)

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

    Jiangmen Sure&Me Medical Product CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
    Device Description
    The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8) The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask. The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line. The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device. The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm*1cm±0.2cm (L*W), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm*0.4cm(L*W). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm*2.5mm* 0.45mm (L*W*H).
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