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510(k) Data Aggregation

    K Number
    K082822
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZIBO ZHUANGYUAN PLASTIC PRODUCTS COMPANY
    Date Cleared
    2008-10-22

    (27 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    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 contammation between patient and examiner.

    Device Description

    powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed study data for a novel device. Therefore, much of the requested information about study design, sample sizes, and expert adjudication for an AI/algorithm-based device is not applicable to this submission.

    Here's a breakdown of the available information:

    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 & D6124-01
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