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510(k) Data Aggregation

    K Number
    K031072
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E
    Manufacturer
    SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
    Date Cleared
    2003-05-06

    (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 EXAMINER.

    Device Description

    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves With Vitamin E". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not describe acceptance criteria for a study, nor does it present the results of a study to prove a device meets acceptance criteria. The structure of the request, with questions about sample size, expert ground truth, adjudication methods, and AI performance, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices or diagnostic tests.

    This letter solely concerns the regulatory clearance of a physical medical device (examination gloves), not an AI/ML algorithm or a diagnostic test with performance metrics of the type requested. Therefore, none of the specific questions can be answered from the provided text.

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