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510(k) Data Aggregation

    K Number
    K220066
    Device Name
    Medical Nitrile Examination Gloves
    Date Cleared
    2022-04-03

    (83 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hunan Zhenheyikang Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.
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    K Number
    K213724
    Device Name
    Medical Surgical Mask
    Date Cleared
    2022-02-20

    (86 days)

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

    Hunan Zhenheyikang Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 as sterile.
    Device Description
    The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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 lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.
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