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510(k) Data Aggregation

    K Number
    K081040
    Device Name
    POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Manufacturer
    PT. SHAMROCK MANUFACTURING CORP.
    Date Cleared
    2008-05-20

    (39 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

    A palient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Powdered Latex Examination Gloves

    AI/ML Overview

    This document is a marketing authorization letter for "Powdered Latex Examination Gloves" and does not contain information about the acceptance criteria or a study proving a device meets them.

    The letter is from the FDA to PT. Shamrock Manufacturing Corporation, confirming that their gloves are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions.

    Therefore, I cannot provide the requested information.

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