LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993737
    Device Name
    MIGHTY MAN (DYNAMIC LINKERS)
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2000-03-20

    (137 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 :

    MIGHTY MAN (DYNAMIC LINKERS)

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

    Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

    Device Description

    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

    AI/ML Overview

    The provided text is a 510(k) summary for a latex condom, and it does not contain any information about acceptance criteria, device performance studies (beyond conformance to ASTM D 3492), or details about ground truth, sample sizes, or expert adjudication specific to an AI/ML device.

    Therefore, I cannot fulfill your request for the specific information regarding an AI/ML device's acceptance criteria and studies from this document. This document is related to a traditional medical device (condom) and its premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1