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510(k) Data Aggregation

    K Number
    K991892
    Device Name
    TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
    Manufacturer
    LINE ONE LABORATORIES
    Date Cleared
    1999-08-19

    (77 days)

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

    TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR

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

    This Device is A latex Condom: designed to Prevent PREGNANCY & help reduce the Risk. OF TRANSMISSION TO sexually transmitted diseases.

    Device Description

    latex Condom

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for two brands of condoms: Trustex® and Impulse® Mint Flavored Condoms in Green Color. As such, it does not contain the information requested about acceptance criteria and a study proving a device meets them.

    The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed. It discusses regulatory compliance, labeling requirements (including expiration dating), and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

    The document does not contain:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for any study.
    • Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

    Therefore, I cannot provide the requested information from this document.

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