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510(k) Data Aggregation

    K Number
    K110945
    Date Cleared
    2011-09-13

    (162 days)

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

    Powder-free yellow synthetic vinyl patient examination gloves 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

    Powder-free yellow synthetic vinyl patient examination gloves that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary, focusing on the acceptance criteria and study details:

    Acceptance Criteria and Device Performance

    The device in question is a "Powder-free yellow synthetic vinyl patient examination glove." The summary indicates that the device's performance was evaluated against established standards for patient examination gloves.

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 and D6124-01
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