LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K093335
    Device Name
    LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2010-06-18

    (235 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 :

    LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)

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

    Laglove TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

    Device Description

    Laglove ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Pink Color)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria and study details for a medical device's performance. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness profiles.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1