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510(k) Data Aggregation

    K Number
    K230832
    Device Name
    Powdered Free Sterile Natural Rubber Latex Surgical Gloves
    Manufacturer
    The Egyptian Company For Medical & Electronic Industries
    Date Cleared
    2023-08-16

    (142 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211953
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Egyptian Company For Medical & Electronic Industries

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

    The powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    The device is a sterile, single-use, non-pyrogenic, latex surgical glove. The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand. The Glove palm has textured surface.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device: "Powdered Free Sterile Natural Rubber Latex Surgical Gloves." This document describes the device, its intended use, and comparative non-clinical performance testing against a predicate device to demonstrate substantial equivalence.

    It does not describe:

    • An AI/ML-driven device.
    • A study proving an AI/ML meets acceptance criteria.
    • Any ground truth establishment or expert adjudication.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Training set details.

    Therefore,Based on the provided FDA 510(k) Summary for "Powdered Free Sterile Natural Rubber Latex Surgical Gloves," the document does not describe an AI/ML-driven device or any study related to AI/ML performance.

    The 510(k) submission focuses on demonstrating substantial equivalence of the surgical gloves to a predicate device through non-clinical performance testing. The information requested in the prompt, such as acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable to the content of this document, as it pertains to a physical medical device (surgical gloves) and not a software algorithm or AI.

    Therefore, I cannot extract the requested information from the provided text.

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