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510(k) Data Aggregation

    K Number
    K993887
    Device Name
    ALATECH LATEX CONDOM
    Manufacturer
    ALATECH HEALTHCARE, LLC.
    Date Cleared
    1999-12-20

    (34 days)

    Product Code
    HIS
    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

    The Alatech Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    Alatech Male Natural Latex Condom

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a medical device (Alatech Lubricated Male Latex Condom) and its indications for use. It does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, which are typically found in a detailed study report or premarket submission summary. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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