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510(k) Data Aggregation

    K Number
    K033163
    Device Name
    CAUTION CONDOMS
    Manufacturer
    RICHARD VAN HAUSSEN AMERICA, INC.
    Date Cleared
    2004-04-27

    (172 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICHARD VAN HAUSSEN AMERICA, INC.

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

    Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

    Device Description

    Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9

    AI/ML Overview

    This document is a 510(k) clearance letter for "Caution Condoms - Male latex condoms, lubricated, with and without Nonoxynol-9." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation document for a diagnostic or AI-based device.

    The letter confirms that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, rather than a specific performance study against defined acceptance criteria in the manner requested.

    Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and performance study details from this document. The document primarily concerns regulatory clearance for a medical device (condoms) based on substantial equivalence, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment relevant to the provided questions.

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