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510(k) Data Aggregation

    K Number
    K042250
    Device Name
    SENSATOUCH
    Date Cleared
    2004-11-12

    (84 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALUNA MANAGEMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SensaTouch™ is indicated as an aid for performing breast self-examinations.
    Device Description
    The SensaTouch™ - Breast Self-Exam Glove is a very thin double wall polyurethane glove, 8 inches in diameter containing a small quantity of colored lubricating fluid. The very thin nature of the polyester polyurethane allows the glove to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible glove, provides easy sliding between the upper and lower surfaces of the glove. Therefore, when properly used between the fingers and the soft breast tissues of the patient, a reduction of friction is observed.
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