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510(k) Data Aggregation

    K Number
    K172414
    Device Name
    JUD custom fit condom
    Manufacturer
    Global Mailer Partners, LLC
    Date Cleared
    2017-10-12

    (63 days)

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

    Global Mailer Partners, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom. JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.
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