LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022701
    Device Name
    POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2002-09-17

    (34 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

    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

    Powder-free, Latex Examination Glove coated with Aloe Vera gel and Vitamin E.

    AI/ML Overview

    This document is exclusively a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove coated with Aloe Vera and Vitamin E.

    A 510(k) clearance solely addresses the substantial equivalence of a new device to a predicate device. It does not involve studies to establish acceptance criteria for device performance in the way that would typically be done for AI/ML-driven medical devices.

    Therefore, none of the requested information (table of acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set details) is present in this document because it is not relevant to a 510(k) submission for this type of medical device (gloves).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1