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510(k) Data Aggregation

    K Number
    K030176
    Device Name
    LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
    Manufacturer
    SURETEX, LTD.
    Date Cleared
    2003-04-17

    (90 days)

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

    SURETEX, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
    Device Description
    These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.
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    K Number
    K010371
    Device Name
    LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
    Manufacturer
    SURETEX, LTD.
    Date Cleared
    2001-04-27

    (79 days)

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

    SURETEX, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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