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510(k) Data Aggregation

    K Number
    K022671
    Device Name
    FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2002-11-18

    (98 days)

    Product Code
    LZA
    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

    The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    FreeForm Blue Powder Free Nitrile Examination Gloves

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "FreeForm Blue Powder Free Nitrile Examination Gloves." It does not contain information about a study proving the device meets acceptance criteria, an AI system, or performance metrics typically associated with medical device studies.

    The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined it is as safe and effective as a device already on the market. This type of clearance does not typically involve the detailed performance studies or AI-specific information requested in your prompt.

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

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