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510(k) Data Aggregation

    K Number
    K973903
    Device Name
    POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-12-17

    (64 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

    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or and finger to prevent contamination between patient examiner.

    Device Description

    Powderfree Patient Nitrile Examination Glove ( Blue Colour )

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Powderfree Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter is a regulatory approval for a physical medical product (gloves) based on substantial equivalence to previously marketed devices, not an evaluation of a data-driven device.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document.

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