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510(k) Data Aggregation

    K Number
    K983725
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
    Manufacturer
    OMNIGRACE LTD.
    Date Cleared
    1998-12-07

    (46 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 medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Omni Touch Nitrile Examination Glove, Powdered, Blue

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: "Omni Touch Nitrile Examination Glove, Powdered, Blue." It signifies that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (sample size, provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is a regulatory approval, not a scientific study report.

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