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510(k) Data Aggregation

    K Number
    K100075
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
    Manufacturer
    TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2010-02-26

    (46 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K051156
    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, Colored (White)

    AI/ML Overview

    The provided information describes a K100075 premarket notification for "Powder-free Vinyl Patient Examination Gloves, Colored (White)". This is a medical device subject to general controls and a substantial equivalence determination, not an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable because these types of studies are not typically conducted for this class of device.

    However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance CriteriaDevice 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 D6124-06
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