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510(k) Data Aggregation

    K Number
    K200967
    Device Name
    mCare(R) Powder Free Nitrile Orange Examination Gloves
    Manufacturer
    Mercator Medical (Thailand) LTD.
    Date Cleared
    2020-06-06

    (57 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    mCare(R) Powder Free Nitrile Orange Examination Gloves

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

    mCare® Powder Free Nitrile Orange Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    mCare® Powder Free Nitrile Orange Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: "mCare® Powder Free Nitrile Orange Examination Gloves."

    This document does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. It is a regulatory clearance for a physical product (gloves).

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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