LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993605
    Device Name
    PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-12-20

    (56 days)

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

    PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES

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

    Pepper Green Mint Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Pepper Green Mint Powdered Latex Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory clearance for a medical device (gloves), not a performance study or a report on AI/software device validation.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1