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510(k) Data Aggregation

    K Number
    K113194
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
    Manufacturer
    SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
    Date Cleared
    2012-05-14

    (196 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K102558
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloves,White 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,White 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 a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.

    Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)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 D6124-06
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