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510(k) Data Aggregation

    K Number
    K022781
    Device Name
    MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
    Manufacturer
    INDUSTRIAL CLOTHINGS, LTD.
    Date Cleared
    2002-10-08

    (47 days)

    Product Code
    LZA
    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

    Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove, which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. This type of document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are typically found in the 510(k) submission itself, not the clearance letter.

    Therefore, I cannot provide the requested information from the provided text. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls.

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