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510(k) Data Aggregation

    K Number
    K971731
    Device Name
    UNIGLOVES
    Manufacturer
    UNI-GLOVE (USA), INC.
    Date Cleared
    1997-08-05

    (88 days)

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

    UNI-GLOVE (USA), 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. For Medical Use
    Device Description
    Uni-Gloves Brand Patient Examination Glove (Powder-Free)
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