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510(k) Data Aggregation

    K Number
    K973058
    Device Name
    PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-11-07

    (81 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 finger to prevent contamination between patient and examiner.

    Device Description

    Patient Nitrile Examination Glove (Powderfree)

    AI/ML Overview

    This document is primarily a 510(k) clearance letter from the FDA for a "Patient Nitrile Examination Glove (Powderfree)". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter is a regulatory approval notice, not a performance study report.

    Therefore, I cannot extract the requested information from the provided text.

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