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510(k) Data Aggregation

    K Number
    K050244
    Device Name
    MALE NATURAL RUBBER LATEX CONDOM
    Date Cleared
    2005-04-08

    (65 days)

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

    NRS GLOBAL PARTNERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NRS Global Partners 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 sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. This condom is identical to the predicate device with respect to design, physical properties, and formulation.
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