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510(k) Data Aggregation

    K Number
    K151208

    Validate with FDA (Live)

    Device Name
    Powder Free Nitrile Examination Glove
    Manufacturer
    VRG KHAI HOAN JOINT STOCK COMPANY
    Date Cleared
    2015-09-14

    (131 days)

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

    A 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 NITRILE EXAMINATION GLOVE

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

    The letter is a regulatory document confirming that the gloves are substantially equivalent to a legally marketed predicate device. It discusses regulatory compliance, labeling, and other administrative details.

    Therefore, I cannot provide the requested information based on the provided text.

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