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510(k) Data Aggregation

    K Number
    K990746
    Device Name
    SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
    Date Cleared
    1999-03-23

    (15 days)

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

    SOUTHLAND PRODUCTS CO., LTD.

    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 hands or fingers to prevent contamination between patient and examiner.
    Device Description
    Powderfree patient latex examination gloves, with protein label claim ( 50 micrograms or less of total water extractable protein per gram.)
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    K Number
    K990751
    Device Name
    SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
    Date Cleared
    1999-03-23

    (15 days)

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

    SOUTHLAND PRODUCTS CO., LTD.

    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 hands or fingers to prevent contamination between patient and examiner.
    Device Description
    Powderfree( Polymer coated ) patient latex examination gloves
    Ask a Question

    Ask a specific question about this device

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