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510(k) Data Aggregation

    K Number
    K102976
    Device Name
    POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    HEZE JUXINYUAN FOOD CO., LTD
    Date Cleared
    2010-12-13

    (68 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K091662
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powdered Vinyl Patient Examination Gloves, Clear (non-colored) 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

    Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06 e1.Meets
    Physical PropertiesASTM standard D 5250-06 e1.Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder AmountASTM standard D 5250-06 e1 and D6124-06Meets (
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