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510(k) Data Aggregation

    K Number
    K051156
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
    Manufacturer
    SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
    Date Cleared
    2005-06-14

    (41 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K042119
    Why did this record match?
    Device Name :

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)

    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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.

    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, Colored (White, Yellow)":

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-00e4Meets
    Physical PropertiesASTM standard D 5250-00e4Meets
    Freedom from Pinhole21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-00e4 and D6124-01Meets (
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