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510(k) Data Aggregation

    K Number
    K211516
    Device Name
    Disposable Vinyl Nitrile Synthetic Gloves Powder Free
    Manufacturer
    Tangshan Hongyun Plastic Products Co., Ltd.
    Date Cleared
    2021-08-24

    (99 days)

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

    Tangshan Hongyun Plastic Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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    K Number
    K141878
    Device Name
    HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2014-12-24

    (166 days)

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

    TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder-Free Yellow Vinyl Patient Examination Gloves is a non sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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