LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993258
    Device Name
    SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    SUPERMAX SDN BHD
    Date Cleared
    1999-10-27

    (28 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 nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

    Device Description

    POWDER FREE NITRILE EXAMINATION GLOVES

    AI/ML Overview

    The provided document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves" (K993258). It does not contain sections detailing acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    This document is from 1999 and pertains to a physical medical device (gloves), not an AI/ML powered device. Therefore, the requested information categories are not applicable to the content of this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1