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510(k) Data Aggregation

    K Number
    K162511
    Device Name
    LELO RESPECT HEX Natural Rubber Latex Condom
    Manufacturer
    LELO INC.
    Date Cleared
    2017-01-13

    (127 days)

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

    LELO RESPECT HEX Natural Rubber Latex Condom

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

    The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "LELO RESPECT HEX Natural Rubber Latex Condom." This document primarily concerns the regulatory approval of a medical device (a condom) and does not contain information about the acceptance criteria, device performance results, or study details (like sample sizes, expert qualifications, or ground truth establishment) typically associated with AI/ML device evaluations.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from this document. The document confirms the device's substantial equivalence to a predicate device for contraception and prophylactic purposes.

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