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510(k) Data Aggregation

    K Number
    K021013
    Device Name
    SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2002-05-22

    (54 days)

    Product Code
    LZA
    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

    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Sterile Nitrile Examination Gloves (Powdered Free)

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Smart Glove Sterile Nitrile Examination Gloves Powder free." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt.

    Therefore, I cannot extract the requested information from the provided text.

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