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510(k) Data Aggregation

    K Number
    K990698
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
    Manufacturer
    OMNIGRACE (THAILAND) LTD.
    Date Cleared
    1999-05-13

    (71 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 worn 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, Purple

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for "Omni Touch Nitrile Examination Glove, Powdered, Purple," which confirms the device's substantial equivalence to predicate devices and permits its marketing.

    The letter and the attached "Indications For Use Statement" do not detail:

    • Specific acceptance criteria for the device beyond its intended use as a medical glove.
    • Any performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

    Therefore, I cannot fulfill your request with the provided information.

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