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510(k) Data Aggregation

    K Number
    K093264
    Device Name
    VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
    Manufacturer
    QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
    Date Cleared
    2010-05-28

    (221 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 Vinyl examination glove , Powder Free, Clear( Non-Colored ) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Vinyl Examination Glove, Powder Free, Non-Colored

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification acceptance letter from the FDA regarding a "Vinyl Examination Glove, Powder Free, Non-Colored." This document does not contain information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

    The request asks for specific details related to the evaluation of an AI-powered medical device, such as:

    • Acceptance criteria and reported device performance.
    • Sample size and data provenance for test sets.
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC study results, if applicable.
    • Standalone performance.
    • Type of ground truth used.
    • Training set sample size and ground truth establishment.

    None of this information is present in the provided FDA letter for a VINYL EXAMINATION GLOVE. This device is a Class I medical device (patient examination glove) and not an AI/ML-based diagnostic or analytical tool. Evaluation for such devices primarily focuses on material safety, barrier integrity, and physical properties, not on algorithmic performance or expert consensus for interpretation.

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