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510(k) Data Aggregation

    K Number
    DEN210034
    Device Name
    ONE Male Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2022-02-23

    (181 days)

    Product Code
    QRZ, ORZ
    Regulation Number
    884.5305
    Why did this record match?
    Product Code :

    QRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.
    Device Description
    The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated. The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted.
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