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510(k) Data Aggregation

    K Number
    K013998
    Device Name
    POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    2002-02-13

    (71 days)

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

    SHEEN MORE ENT. 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 on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES, Class I Device, 80LZA
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    K Number
    K001637
    Device Name
    DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    2000-06-23

    (24 days)

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

    SHEEN MORE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001065
    Device Name
    DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    2000-05-23

    (50 days)

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

    SHEEN MORE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001155
    Device Name
    DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    2000-05-23

    (43 days)

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

    SHEEN MORE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000226
    Device Name
    DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    2000-03-02

    (35 days)

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

    SHEEN MORE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992686
    Device Name
    DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
    Manufacturer
    SHEEN MORE ENT. CO., LTD.
    Date Cleared
    1999-09-24

    (45 days)

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

    SHEEN MORE ENT. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
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