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510(k) Data Aggregation

    K Number
    K970216
    Device Name
    NITRILE EXAMINATION GLOVES-PRE POWDERED
    Manufacturer
    INFLUX PACIFIC SDN. BHD.
    Date Cleared
    1997-09-26

    (253 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K974710,K980677
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    NITRILE EXAMINATION GLOVES ( POWDERED

    AI/ML Overview

    The provided text is related to a 510(k) clearance letter from the FDA for "Nitrile Powdered Examination Gloves." It does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device, as none of this information is present in the provided document.

    The document primarily focuses on the FDA's determination of substantial equivalence for the nitrile gloves to predicate devices and outlines regulatory responsibilities.

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