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510(k) Data Aggregation

    K Number
    K050360
    Device Name
    TULIP CONDOM
    Manufacturer
    SHANGHAI LATEX FACTORY
    Date Cleared
    2005-03-01

    (15 days)

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

    SHANGHAI LATEX FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tulip 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 latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, nominal length 180mm, nominal width 52mm, and nominal thickness 0.05mm. It is lubricated with silicon, with cornstarch as a dressing material. The condom is offered in natural latex color and is designed to conform to established American and international voluntary standards including ASTM D3492-02 and ISO 4074-1-1996
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