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    K Number
    K203541
    Device Name
    Okamoto 002 Lubricated Polyurethane Male Condom
    Manufacturer
    Okamoto U.S.A. Inc.
    Date Cleared
    2022-02-25

    (449 days)

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

    Okamoto U.S.A. Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.
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