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510(k) Data Aggregation

    K Number
    K980174
    Device Name
    DUREX COLORS AND SCENTS
    Manufacturer
    LONDON INTL. LLC.
    Date Cleared
    1998-08-13

    (205 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DUREX COLORS AND SCENTS

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

    A latex rubber condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and the spread of sexually transmitted diseases.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the clearance of Durex Colors and Scents Latex Rubber Condoms (K980174). It does not contain information about acceptance criteria, study details, or performance data for a device in the manner requested by your prompt (e.g., sample sizes, expert qualifications, ground truth, or MRMC studies).

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of preventing pregnancy and the spread of sexually transmitted diseases. However, it does not provide the specific technical acceptance criteria or the study data that would demonstrate how the device meets such criteria.

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