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510(k) Data Aggregation

    K Number
    K993247
    Device Name
    NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
    Manufacturer
    JDA INTL., INC.
    Date Cleared
    1999-11-05

    (38 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    JDA INTL., INC.

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

    The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Nitrile Powder Free Patient Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of medical devices that typically involve AI or complex algorithms.

    The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This determination is based on the device meeting general controls provisions and Good Manufacturing Practice (GMP) regulations, not on specific performance metrics from a clinical study as would be described for an AI-powered diagnostic device.

    Therefore, I cannot provide the requested information from the provided document.

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