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510(k) Data Aggregation

    K Number
    K051924
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
    Manufacturer
    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
    Date Cleared
    2005-09-02

    (49 days)

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

    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powdered vinyl 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 patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
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    K Number
    K051156
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
    Manufacturer
    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
    Date Cleared
    2005-06-14

    (41 days)

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

    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder free vinyl 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 vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.
    Ask a Question
    K Number
    K042120
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
    Date Cleared
    2004-11-04

    (90 days)

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

    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This powdered, vinyl 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 (21CFR 880.6250).
    Device Description
    powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-004.
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    K Number
    K042119
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
    Manufacturer
    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
    Date Cleared
    2004-11-03

    (89 days)

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

    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,

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

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