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