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510(k) Data Aggregation

    K Number
    K223003
    Device Name
    Banded Face Mask
    Date Cleared
    2022-11-18

    (50 days)

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

    Hubei Medlink Healthcare Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The banded face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The face mask is 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
    Banded Face Mask
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    K Number
    K214087
    Device Name
    Medical Face Mask
    Date Cleared
    2022-03-08

    (71 days)

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

    Hubei Medlink Healthcare Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 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. The face mask is 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 Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Malleable polyethylene wire. The medical face masks are available in five sizes, 17.5*9.5cm, 15.5*9.5cm, 14.5*9.5cm, 14*9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
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