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510(k) Data Aggregation

    K Number
    K994311
    Device Name
    MALE LATEX CONDOM WITH VANILLA FLAVOR
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-03-21

    (90 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 :

    MALE LATEX CONDOM WITH VANILLA FLAVOR

    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

    Male Natural Rubber Latex Condom with Vanilla Flavor, 56 mm width

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a male latex condom. It discusses the regulatory classification, general controls, and labeling requirements for the device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies for AI devices.

    Therefore, I cannot provide the requested information based on the given input. The document is for a medical device (a condom), not an AI/ML powered device.

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