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510(k) Data Aggregation

    K Number
    K024174
    Device Name
    NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
    Manufacturer
    GENERAL GLOVES CORP.
    Date Cleared
    2003-01-28

    (41 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    POWDER FREE VINYL EXAMINATION GLOVES

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to General Gloves Corporation regarding "Powder Free Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    It primarily serves as:

    • A confirmation of the FDA's review and their determination of substantial equivalence for the device to legally marketed predicate devices.
    • An authorization for General Gloves Corporation to market the device, subject to general controls of the Act.
    • A reminder of the company's responsibilities under various FDA regulations.
    • A statement of Indications for Use for the device.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. The document is a regulatory approval letter, not a detailed study report.

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