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510(k) Data Aggregation

    K Number
    K211236
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Tangshan Hongyun Healthcare Products Co., Ltd.
    Date Cleared
    2021-09-27

    (154 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

    The Disposable Vinyl Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    Disposable Vinyl Examination Gloves

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for "Disposable Vinyl Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria, as it pertains to medical gloves, not a diagnostic or AI-powered device.

    The questions in the prompt are typical for evaluating a new diagnostic or AI-driven medical device submission, which would involve performance metrics like sensitivity, specificity, accuracy, and detailed study methodologies. This document is a regulatory clearance for a Class I medical device (non-powdered patient examination glove) which typically relies on established performance standards for physical properties rather than clinical performance studies described by the questions.

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