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510(k) Data Aggregation

    K Number
    K031369
    Device Name
    MERCATOR HEALTHCARE MALE LATEX CONDOM
    Manufacturer
    MERCATOR HEALTHCARE LTD.
    Date Cleared
    2003-10-31

    (184 days)

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

    MERCATOR HEALTHCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercator male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
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