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510(k) Data Aggregation

    K Number
    K191898
    Device Name
    Sterile Latex Powder-Free Surgical Gloves
    Manufacturer
    Modern Healthcare Corp.
    Date Cleared
    2019-12-18

    (155 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    Sterile Latex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and are intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

    AI/ML Overview

    I am sorry to inform you that the provided text is a 510(k) clearance letter from the FDA for Sterile Latex Powder-Free Surgical Gloves.

    This document does not contain information about a medical device that utilizes AI or algorithms, nor does it discuss acceptance criteria, study data, or ground truth establishment relevant to AI/ML device performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the document does not contain this type of information. It is a regulatory document for a physical medical device (gloves).

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