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510(k) Data Aggregation

    K Number
    K210622
    Device Name
    Single-Use Medical Face Mask
    Date Cleared
    2021-10-08

    (220 days)

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

    Jiangxi Hongda Medical Equipment Group Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The single-use medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face 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, provided sterile and non-sterile.
    Device Description
    The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are held in place over the users' mouth and nose by ear loops/ ties welded to the mask. The nose clip is made of polypropylene and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-19, which are provided in following table. The difference of the level 1, level 2 and level 3 masks is the gram weight of the melt-blown nonwoven. The gram weight of the melt-blown nonwoven for level 1 is 30g/m², and that for level 2 and level 3 masks is 40g/m². Level 2 and level 3 masks are exactly the same and are divided into level 2 and level 3 just for marking. The proposed devices are provided in sterile and non-sterile two types.
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