Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030994
    Manufacturer
    Date Cleared
    2003-06-12

    (76 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

    Device Description

    NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study details for the Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves, based on the provided document:

    Acceptance Criteria and Device Performance

    The device, "Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim (

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1