LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191860
    Device Name
    Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
    Manufacturer
    Semperit Technische Produkte Gesellchaft m.b.H.
    Date Cleared
    2020-03-31

    (264 days)

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

    Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification clearance letter for a medical device: "Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential." This document does not contain any information regarding the acceptance criteria, study details, or performance metrics for a software-based medical device or an AI/ML algorithm.

    The information requested in the prompt (acceptance criteria, study design, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details) is typically associated with the evaluation of AI/ML-powered diagnostic or prognostic devices. Since the provided document describes a physical medical device (surgical gloves), these specific data points are not present.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent detailed questions about study design, experts, or AI/ML performance based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1