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510(k) Data Aggregation

    K Number
    K103198
    Date Cleared
    2010-12-20

    (52 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 glove 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 Vinyl Patient Examination Gloves, Clear(non-colored)

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)":

    This document describes a 510(k) premarket notification for a medical device -- Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The studies conducted are non-clinical, primarily focused on meeting established material and performance standards for patient examination gloves.


    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance 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 D6124-06Meets (
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