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510(k) Data Aggregation

    K Number
    K033877
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
    Manufacturer
    ONE TOUCH PRODUCTS CO., LTD.
    Date Cleared
    2004-01-16

    (32 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 EYAMINER EXAMINER.

    Device Description

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Synthetic Examination Glove. It does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert involvement, or any data related to the performance of an AI/ML device.

    Therefore, I cannot provide the requested information. The document is a regulatory approval letter for a physical medical device (gloves), not an AI/ML algorithm requiring a performance study as described in your prompt.

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