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510(k) Data Aggregation

    K Number
    K120394
    Device Name
    LIFESTYLES ZERO LUBRICATED LATEX CONDOM
    Manufacturer
    ANSELL HEATHCARE PRODUCTS LLC
    Date Cleared
    2012-05-08

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSELL HEATHCARE PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.
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