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510(k) Data Aggregation

    K Number
    K013333
    Device Name
    LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM
    Manufacturer
    INNOVATIVE GLOVES CO; LTD
    Date Cleared
    2001-12-07

    (59 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K013333
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purpose than worn on the examiner's hands or fingers to prevent contamination between patient ar. examiner. (21 CER 880.6250)

    Device Description

    LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAMS OF LESS)

    AI/ML Overview

    This document is a 510(k) clearance letter for latex examination gloves. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria for an AI/ML-driven medical device. Therefore, I cannot extract the requested information.

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