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510(k) Data Aggregation

    K Number
    K212011
    Device Name
    Vinyl Powder Free Examination Glove
    Manufacturer
    Top Glove Vietnam Company Limited
    Date Cleared
    2022-02-14

    (231 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 finger to prevent contamination between patient and examiner.

    Device Description

    Vinyl Examination Powder Free Glove

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a Vinyl Powder Free Examination Glove, which is a Class I medical device. This document does not contain any information regarding acceptance criteria, study details, or performance data for an AI/ML-based medical device.

    Therefore, I cannot fulfill your request using the provided input. The document discusses regulatory aspects of a physical product (gloves) and not an AI-powered diagnostic or decision support system.

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