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510(k) Data Aggregation

    K Number
    K070937
    Device Name
    MULTIPLE BRAND MALE LATEX CONDOM
    Manufacturer
    NULATEX SDN. BHD.
    Date Cleared
    2007-09-21

    (170 days)

    Product Code
    HIS,LTZ
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

    The document discusses:

    • The trade name of the device and its classification.
    • The regulatory framework for medical devices.
    • The intended use of the condom.

    It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any study.
    3. Details about experts or ground truth establishment.
    4. Adjudication methods.
    5. MRMC comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. The type of ground truth used.
    8. Training set sample sizes or ground truth establishment for a training set.

    Therefore, I cannot answer your request based on the provided input.

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