LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023715
    Device Name
    STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
    Manufacturer
    STARMATRIX SDN BHD
    Date Cleared
    2003-02-04

    (91 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

    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

    Powder Free Latex Examination Gloves, with Protein Labeling Claim. Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Natural Color

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Powder Free Latex Examination Gloves. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement for an AI/ML powered device.

    Therefore, I cannot provide the requested information. The provided text is solely a regulatory approval document for a medical device (gloves).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1