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510(k) Data Aggregation

    K Number
    K113191
    Date Cleared
    2011-11-17

    (17 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloves, Yellow Color is a non-sterile 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

    Powder Free Vinyl Patient Examination Gloves, Yellow Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Yellow Color" but does not describe a study involving a device that uses AI or requires a human-in-the-loop for its operation.

    Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML models) is not applicable to this medical glove.

    Here's the relevant information that can be extracted:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaStandardReported Device Performance
    DimensionASTM standard D 5250-06 e1.Meets
    Physical PropertiesASTM standard D 5250-06 e1.Meets
    Freedom from Pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 e1 and D6124-06Meets (
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