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510(k) Data Aggregation

    K Number
    K032670
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR
    Manufacturer
    KINGSWELL INTERNATIONAL INC.
    Date Cleared
    2003-11-14

    (77 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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color." This document does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device.

    The letter discusses the substantial equivalence of the gloves to a legally marketed predicate device and the general regulatory requirements for such a device. There is no mention of an algorithm, AI, machine learning, or any performance study related to such a system.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document.

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