LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231740
    Device Name
    MemorialTM Gloves
    Manufacturer
    US Glove Supply
    Date Cleared
    2023-07-04

    (20 days)

    Product Code
    LZA,LZC,OPJ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K223559,K172525
    Why did this record match?
    Device Name :

    MemorialTM Gloves

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

    These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

    Device Description

    US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for Memorial™ Gloves, which are Powder Free, Nitrile Examination Gloves. The submission is a 510(k) premarket notification to the FDA, indicating a claim of substantial equivalence to already marketed predicate devices.

    Here's an analysis of the provided information, framed by your questions:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document presents several tables summarizing non-clinical tests. I will consolidate the key information from pages 15-17.

    Testing/Standards (Parameter)Purpose of the TestAcceptance CriteriaReported Device Performance (Result)
    Physical Properties
    ASTM D-3767 (Dimensions: Length, Width, Thickness)To determine the length, width and thickness of the glovesUS Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) should meet the requirements of ASTM D6319.Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values: Length Min 230mm, Width S 80, M 95, L 110, XL 120, Thickness (Cuff: 0.05 ± 0.02, Palm: 0.07 ± 0.02, Finger: 0.09 ± 0.02))
    ASTM D-412/D-573 (Tensile Strength & Elongation)To determine the Tensile strength and elongation in gloves before aging and after agingBefore aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500%min. After aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400%min.Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values are stated to meet these criteria, consistent with the acceptance criteria.)
    ASTM D-5151 (Leakage/Detection of Holes)Testing for freedom from holes as per ASTM D-5151.The gloves should be free of holes (Meets with the requirement of ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I).Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Stated as meeting ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I)
    ASTM D6124 (Powder Content)To Determine the powder residue using Test Method D6124.2.0 mg MaximumPass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific value stated as Max 1.38 mg/glove, which is
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1