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510(k) Data Aggregation

    K Number
    K131751
    Device Name
    FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
    Manufacturer
    LUCENXIA PRESCIENCE AG
    Date Cleared
    2013-09-25

    (103 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

    A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)

    Device Description

    FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for a medical device: "FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves."

    This document does not contain information about acceptance criteria, device performance, study design, or ground truth establishment for a medical imaging or AI-based device. Instead, it's a regulatory clearance for a physical medical product (surgical gloves) based on substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details) from the provided text.

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