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510(k) Data Aggregation

    K Number
    K022368
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
    Manufacturer
    CANOPUS MEDICAL SUPPLY CO., LTD.
    Date Cleared
    2002-09-05

    (45 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 EXAM GLOVES, WITH VITAMIN E

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a letter from the FDA regarding a 510(k) premarket notification for "Disposable Powder Free Vinyl Examination Gloves, with Vitamin E." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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