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510(k) Data Aggregation

    K Number
    K991689
    Device Name
    LATEX EXAMINATION GLOVES (POWDER FREE)
    Date Cleared
    1999-06-24

    (37 days)

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

    USG HEALTHGUARD SDN BHD

    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 finger to prevent contamination between patient and examiner.
    Device Description
    Powder-Free, Latex Patient Examination Gloves
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    K Number
    K991690
    Device Name
    LATEX EXAMINATION GLOVES (PRE POWDERED)
    Date Cleared
    1999-06-24

    (37 days)

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

    USG HEALTHGUARD SDN BHD

    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 finger to prevent contamination between patient and examiner.
    Device Description
    Latex Patient Examination Gloves (Pre-powdered)
    Ask a Question

    Ask a specific question about this device

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