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510(k) Data Aggregation

    K Number
    K050277
    Device Name
    CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2005-06-07

    (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

    The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.

    Device Description

    Chlorinated Powder Free Latex Examination Gloves (Yellow)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Chlorinated Powder Free Latex Examination Gloves (Yellow). It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.

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