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510(k) Data Aggregation

    K Number
    K030483
    Device Name
    SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    2003-03-06

    (20 days)

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

    EMERALD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potentially infectious and other contaminants.
    Device Description
    A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material.
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    K Number
    K030484
    Device Name
    SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    2003-03-06

    (20 days)

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

    EMERALD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Emerald Medical, Inc. Syntheticare Powdered Vinyl Patient Examination Gloves
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    K Number
    K964919
    Device Name
    EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    1997-01-28

    (50 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMERALD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
    Device Description
    The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
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    K Number
    K961581
    Device Name
    EMERALD STERILE GAUZE SPONGE
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    1996-05-28

    (34 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMERALD MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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