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510(k) Data Aggregation

    K Number
    K040071
    Device Name
    ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
    Date Cleared
    2004-06-03

    (141 days)

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

    ELITE INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, YELLOW GOLD COLOR
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    K Number
    K032616
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    Date Cleared
    2003-10-02

    (38 days)

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

    ELITE INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
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    K Number
    K031113
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
    Date Cleared
    2003-06-10

    (63 days)

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

    ELITE INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
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    K Number
    K031134
    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVES
    Date Cleared
    2003-05-20

    (41 days)

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

    ELITE INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDERED VINYL EXAM GLOVES
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