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510(k) Data Aggregation

    K Number
    K982611
    Device Name
    UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
    Manufacturer
    UNIJECT GLOVES PCL
    Date Cleared
    1998-11-02

    (129 days)

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

    An Examination Gloves 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

    UNIJECT EXAMINATION GLOVES POWDER FREE

    AI/ML Overview

    I am sorry, but the provided text is a regulatory clearance letter from the FDA for medical gloves. It does not contain information about the acceptance criteria or a study proving device performance for an AI/ML powered device. Therefore, I cannot generate the requested table and details.

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