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510(k) Data Aggregation

    K Number
    K012653
    Device Name
    MALE LATEX CONDOM
    Manufacturer
    QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD
    Date Cleared
    2001-09-21

    (39 days)

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

    QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Qingdao Shuang 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, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, and is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600. This condom is lubricated with silicone.
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