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510(k) Data Aggregation

    K Number
    K024324
    Device Name
    LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
    Manufacturer
    GLOBAL PROTECTION CORP.
    Date Cleared
    2003-03-25

    (89 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 :

    LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9

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

    The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.

    Device Description

    Non-spermicidal Lubricated male Latex Condom

    AI/ML Overview

    The provided text is a scanned letter from the FDA regarding the 510(k) clearance for a "Non-spermicidal Lubricated male Latex Condom". It outlines the regulatory status and requirements for such devices.

    However, the provided document does not contain any information about acceptance criteria for a device, nor does it describe any study (clinical or otherwise) that proves the device meets specific acceptance criteria.

    The document primarily focuses on:

    • The FDA's decision of "substantial equivalence" for the device based on a 510(k) submission.
    • Regulatory requirements for marketing the device, including general controls, specific regulations like 21 CFR 801.435 for condom labeling and expiration dating, and Good Manufacturing Practice (GMP).
    • The "Indications for Use" statement for the condom.

    Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study from this document. The prompt asks for details about a study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, none of which are present in these pages.

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