Standards

US Food and Drug Administration (510K) Certification

Manufactured in FDA registered facilities utilizing an FDA registered 510K formulation.   Meets US Government 21-CFR specifications: acceptable for use in food and pharmaceutical applications.

American Standards of Trade and Manufacturing (ASTM)

ASTM 412            

Standard test method for Vulcanized Rubber and Thermoplastic Elastometers

ASTM 573            

Standard test method for Rubber Deteriorization in an Air Oven

ASTM 3767            

Standard practice for Rubber Measurement of Dimensions

ASTM 5151            

Standard Test Method for Detection of Holes in Medical Gloves.

ASTM 5151            

Standard Test Method for Detection of Holes in Medical Gloves.

ASTM 6124            

Standard Test Method for Electrical Conductivity of Aviation and Distillate Fuels

ASTM 6319            

Specification for nitrile examination gloves for medical application

ASTM 6978            

Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

Health Canada – Medical Device Licensing & Registry

The Country of Canada

European MDD Classification and Compliance

Council Directive 93/42/EEC. Gloves are classified as Class l Medical Device as per Annex Vlll of the Medical Device Regulation 2017/745 and are compliant with the following standards: EN455-1, EN 455-2, EN 455-3, IN ISO 13485,: 2016, EN 374-1, EN 374-2, EN-374-3, EN-374-4, EN 374-5, EN ISO 9001,: 2015, ISO EN 420, EN ISO 6124

EN 374 – Dangerous Chemicals and Micro Organisms

EN 374-1: 2020        

Terminology and performance requirements for chemical risks.

EN 374-2: 2020        

Determination of Resistance to Penetration.

EN 374-3: 2020        

Permeation by liquid chemical under conditions of continuous contact

EN 374-4: 2020         

Determination of resistance to degradation by chemicals

EN 374-5: 2020         

Terminology and performance requirements for micro-organisms risks.

EN 455 – Medical Device for Single Use

EN 455-1              

Requirements and testing for freedom from holes

EN 455-2               

Requirements and testing for physical properties

EN 455-3    

Requirements and testing for biological evaluation

EN 420 – General Requirements and Test Methods

EN 420: 2020          

Protective gloves general requirements and test methods

EN ISO – International Standards of Operations

EN ISO 9001:2015        

Quality Management System

EN ISO 10993: 10/11   

Biological Evaluation of Medical Devices for Irritation, Sensitization, and Systemic Toxicity

EN ISO 13485: 2016      

Medical Device Quality Management System