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510(k) Data Aggregation

    K Number
    K030997
    Device Name
    POWDERED VINYL EXAM GLOVES, WHITE
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2003-05-02

    (35 days)

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

    HEYUAN HONGLI INDUSTRIES, INC.

    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 on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ
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    K Number
    K022305
    Device Name
    MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2002-08-08

    (23 days)

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

    HEYUAN HONGLI INDUSTRIES, INC.

    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 on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDER-FREE POLY VINYL EXAM GLOVES, COLOR: WHITE
    Ask a Question
    K Number
    K011413
    Device Name
    POWDER-FREE VINYL EXAM GLOVE, YELLOW
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2001-06-05

    (28 days)

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

    HEYUAN HONGLI INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011414
    Device Name
    POWDERED VINAL EXAM GLOVES
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2001-06-05

    (28 days)

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

    HEYUAN HONGLI INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011412
    Device Name
    POWDER-FREE VINYL EXAM GLOVES
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2001-05-31

    (23 days)

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

    HEYUAN HONGLI INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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