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510(k) Data Aggregation

    K Number
    K983532
    Device Name
    POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    1998-11-30

    (53 days)

    Product Code
    LYZ
    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

    POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLOR (BLUE COLOR)

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device: "Powder-Free Copolymer Nitrile Medical Examination Glove, Blue Color". As such, it is not a study report or clinical trial document that would typically contain the detailed information requested regarding acceptance criteria and device performance studies for AI/ML devices.

    The information provided pertains to the regulatory clearance of a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, not on the performance metrics of a diagnostic algorithm or an AI system.

    Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document as it is not relevant to the subject matter.

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