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510(k) Data Aggregation

    K Number
    K974323
    Date Cleared
    1998-02-10

    (84 days)

    Product Code
    Regulation Number
    884.5300
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    If used properly, condoms will help to 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

    Device Description

    Latex Condoms, Natural Color with Silicone Oil Lubricant

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notifications (K974323) for "Latex Condoms, Natural Color with Silicone Oil Lubricant" does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or multi-reader multi-case studies.

    This document is a letter from the FDA confirming the substantial equivalence of the device to previously marketed devices and an "Indications for Use" statement. It does not include the detailed technical and clinical study information that your request is asking for.

    Therefore, I cannot provide the requested table and information based on the given input.

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