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510(k) Data Aggregation

    K Number
    K012962
    Device Name
    DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (66 days)

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

    DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM

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

    The [No particular brand name] 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

    The provided document is a 510(k) clearance letter from the FDA for a Dotted Condom, Male Natural Rubber Latex Condom. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter explicitly states:

    • "Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

    This indicates that while the manufacturer must have data to support the device's shelf life and performance, this specific FDA clearance letter does not include the details of those studies or acceptance criteria.

    Therefore, I cannot provide the requested information from this document.

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