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510(k) Data Aggregation

    K Number
    K141042
    Device Name
    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
    Manufacturer
    MERCATOR MEDICAL (THAILAND) LTD.
    Date Cleared
    2015-03-19

    (330 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The mCare Powder Free Latex Examination Blue Glove is 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

    mCare Powder Free Latex Examination Blue Glove

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a patient examination glove. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

    The document confirms that Mercator Medical (Thailand) Ltd.'s "mCare Powder Free Latex Examination Blue Glove" is substantially equivalent to legally marketed predicate devices. It discusses general regulatory requirements for medical devices but provides no performance data or study details for this specific product.

    Therefore, I cannot provide the requested information based on the provided text.

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