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510(k) Data Aggregation

    K Number
    K020633
    Device Name
    NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
    Manufacturer
    LS RUBBER SDN BHD
    Date Cleared
    2002-05-15

    (77 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K980964
    Why did this record match?
    Device Name :

    NATURAL AND COLORED LATEX CONDOM WITH FLAVORS

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

    The condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    Device Description

    This condom is made of a natural rubber sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.

    AI/ML Overview

    The provided text is related to a 510(k) submission for male condoms and does not contain information about an AI-powered medical device or a study proving its performance. Therefore, I cannot generate the requested table and study details.

    The document is a submission for a new line of flavored latex condoms, seeking substantial equivalence to a previously approved predicate device. It focuses on the physical characteristics, intended use, and technological characteristics of the condom, as well as regulatory compliance.

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