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510(k) Data Aggregation

    K Number
    K150828
    Device Name
    O-RING Condom
    Date Cleared
    2015-12-18

    (263 days)

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

    O-RING Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom design features a patented illuminated ring on the underneath side of the rolled condom. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is a straight walled with a reservoir tip; nominal length 180mm, nominal flat width 52mm, and nominal thickness 0.07 +/- 0.01 mm. This condom is designed to conform to established national and international voluntary standards (ISO 4074).
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