LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022814
    Device Name
    MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
    Manufacturer
    PT. SMART GLOVE INDONESIA
    Date Cleared
    2003-02-19

    (177 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

    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Nitrile Examination Gloves (Powdered) Blue Pur white colors

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Multiple Nitrile Examination Gloves, Powdered with Purple Blue, White Colors." It is not a study report that includes acceptance criteria and performance data for a device.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is typically found in study reports, clinical trial summaries, or detailed technical documentation, not a 510(k) clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1