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510(k) Data Aggregation

    K Number
    K994118
    Device Name
    OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
    Manufacturer
    GUILIN LATEX FACTORY
    Date Cleared
    2000-08-14

    (252 days)

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

    GUILIN LATEX FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Osmanthus and Gobon condom is used for contraception and frunea.chylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a naural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom (include a brief description of the vondom, such as, a straight-walled, nipple-end, nominal length, nominal width, nominal thickness, etc]. See Tab 1
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