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    K Number
    K131866
    Device Name
    SUSTAIN
    Manufacturer
    HOLLENDER SUSTAINABLE BRANDS LLC
    Date Cleared
    2014-05-01

    (311 days)

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

    HOLLENDER SUSTAINABLE BRANDS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    The SUSTAIN Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods, ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993 Biological Evaluation of Medical Devices.
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