LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992675
    Device Name
    PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
    Manufacturer
    WEAR SAFE MALAYSIA SDN. BHD.
    Date Cleared
    2000-01-20

    (163 days)

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

    PATIENT NITRILE EXAMINATION GLOVES (POWDERED)

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

    A patient Examination Powder 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

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for Patient Exam Nitrile Powdered Gloves. It is not a study of an AI/ML device, and therefore does not contain information about acceptance criteria or a study proving device performance as requested.

    The document is a regulatory approval for a medical glove, confirming its substantial equivalence to previously marketed devices. It does not involve any AI components or performance metrics suitable for the detailed questions about AI device studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1