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510(k) Data Aggregation

    K Number
    K981600
    Device Name
    LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
    Manufacturer
    YOUNG INNOVATIONS LLC DBA PLAK SMACKER
    Date Cleared
    1998-11-02

    (182 days)

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

    YOUNG INNOVATIONS LLC DBA PLAK SMACKER

    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 examiners.
    Device Description
    Latex Patient Examination Gloves BUBBLE GUM FLAVOR PRE-POWDERED
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