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510(k) Data Aggregation

    K Number
    K021041
    Device Name
    WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
    Manufacturer
    W.A. RUBBERMATE CO., LTD.
    Date Cleared
    2002-07-30

    (120 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

    WA Rubbermate Powder-Free Latex Examination Gloves are 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

    WA Rubbermate Powder Free Latex Examination Gloves

    AI/ML Overview

    This document is a letter from the FDA regarding a medical device submission (K021041) for "WA Rubbermate Powder Free Latex Examination Gloves." It is a 510(k) clearance letter, indicating substantial equivalence to a predicate device.

    This document does not contain information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device.

    The provided text focuses on the regulatory aspects of clearing basic medical gloves, which are subject to general controls and not typically supported by the types of studies and performance metrics detailed in the request. Therefore, I cannot extract the requested information from this document.

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