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510(k) Data Aggregation

    K Number
    K022815
    Device Name
    MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
    Manufacturer
    PT. SMART GLOVE INDONESIA
    Date Cleared
    2003-02-13

    (171 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

    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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain information about the acceptance criteria or study details for a device's performance. Therefore, I cannot provide the requested information.

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