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510(k) Data Aggregation

    K Number
    K980511
    Device Name
    NITRILE EXAMINATION GLOVES - POWDER FREE
    Manufacturer
    INFLUX PACIFIC SDN. BHD.
    Date Cleared
    1998-03-13

    (31 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 GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXIMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER

    Device Description

    NITRILE EXAMINATION GLOVES -POWDER FREE

    AI/ML Overview

    The provided document {0-2} is an FDA 510(k) clearance letter for "NITRILE EXAMINATION GLOVES -POWDER FREE." It does not describe any acceptance criteria or a study proving that the device meets those criteria.

    The document indicates that the device 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." The FDA has determined that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This substantial equivalence determination means the FDA did not require a new clinical study to assess its safety and effectiveness.

    Therefore, I cannot provide the requested information about acceptance criteria or a study from this document. The document primarily focuses on regulatory clearance based on substantial equivalence.

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