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510(k) Data Aggregation

    K Number
    K093264
    Device Name
    VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
    Manufacturer
    QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
    Date Cleared
    2010-05-28

    (221 days)

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

    **QINGDAO LANG HUI IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Vinyl examination glove , Powder Free, Clear( Non-Colored ) 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
    Vinyl Examination Glove, Powder Free, Non-Colored
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    K Number
    K093263
    Device Name
    STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
    Manufacturer
    QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
    Date Cleared
    2010-04-30

    (193 days)

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

    **QINGDAO LANG HUI IMPORT **& EXPORT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stretch Vinyl examination glove, Powder Free, Yellow/White 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, Stretch Vinyl Examination Gloves, Yellow/White
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