LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980754
    Device Name
    CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
    Manufacturer
    CROCKER INDUSTRIAL RESOURCES SDN. BHD.
    Date Cleared
    1998-05-18

    (81 days)

    Product Code
    LYY
    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

    CIR latex examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.

    Device Description

    CIR Latex Gloves, Non-Sterile, Powdered [Latex Examination Gloves (Powdered, Non-Sterile) with Protein Labeling Claim of ≤ 200 µg/g]

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "CIR Latex Examination Gloves, Non-Sterile, Powdered, with Protein Labeling Claim of 200uq/q or Less."

    This document does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or comparative effectiveness studies. It is a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the specific information you requested regarding the device's acceptance criteria and the study that proves it meets those criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1