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510(k) Data Aggregation

    K Number
    K971044
    Device Name
    DASH, SULLIVAN, VITAL GARD
    Manufacturer
    DASH MEDICAL GLOVES, INC.
    Date Cleared
    1997-08-25

    (157 days)

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

    DASH MEDICAL GLOVES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient exam glove is a disposable device intended to be worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Not Found
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