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510(k) Data Aggregation

    K Number
    K150414
    Device Name
    Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
    Manufacturer
    INDUSTRIAL CLOTHINGS (PVT) LTD
    Date Cleared
    2015-06-12

    (114 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

    A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves are available with finger textured surface. Sizes; Extra Small and XX-Large.

    Device Description

    Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XS, Model SNAEFT-240OR-XS Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XXL, Model SNAEFT-240OR-XXL

    AI/ML Overview

    This is a 510(k) premarket notification for "Midas Touch-Nitrile Examination Gloves". This document does not describe a study involving device performance metrics, algorithms, human readers, or ground truth as would be found in a submission for an AI/ML-based medical device. Instead, it is an administrative letter from the FDA confirming substantial equivalence for a physical medical device (examination gloves) to predicate devices.

    Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions pertain to acceptance criteria and studies for AI/ML device performance, which are not relevant to this document.

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