Safety & Quality

Glove Standards & Regulations

Standards & Regulations are of significant importance in the glove industry.

Our clients want to be sure to get the best quality glove that complies with national or international standards.

Proven quality assurance is the basic requirement for the high standard of our products and their success in the world market. According to international and national special standards all micro-biological, chemical and physic-technical tests and inspections are carried out, documented and recorded in detail.

Regulations Overview

Medical Device Regulation (MDR)

Medical gloves must comply with the medical device regulation MDR (EU) 2017/745. Medical devices (MD) are categorized into different classes depending on the range of risk involved for the patient.
The basic standard for single-use medical gloves is the EN 455 series, which defines the requirements for freedom from holes, physical properties, dimensions, test methods for bio-compatibility, labeling requirements and especially also requirements concerning the placement of the expiry date.

Personal Protective Equipment Regulation

Protective gloves must comply with the requirements of the directive for the Personal Protective Equipment Regulation (EU) 2016/425. PPE gloves are divided into three different categories depending on the risk against which they are intended to provide protection:

  • Category I: Protection against minimal risks (simple PPE)
  • Category II: Protection against moderate risks
  • Category III: Protection against lethal hazards or serious and irre versible damage to health (complex PPE)


European Norm certification indicates compliances with the European Quality System Regulation (QSR)

  • EN (ISO) 374: Protection against dangerous chemicals and micro-organisms 
  • EN 374-1: Terminology and performance requirements for chemical risks. 
  • EN 374-2: Determination of resistance to penetration. 
  • EN 374-4: Determination of resistance to degradation by chemicals. 
  • EN 374-5: Terminology and performance requirements for micro-organisms risks. 
  • EN 16523-1: Determination of material resistance to permeation by chemicals. 
  • EN 388: Protection against mechanical risk
  • EN 420: Describing general standards for protective gloves
  • EN 455: Medical Gloves for Single-use
  • EN 455-1: Specification for freedom of holes (barrier properties) 
  • EN 455-2: Specification for physical properties 
  • EN 455-3: Requirements and testing for biological evaluation (biological properties/labeling)
  • EN 455-4: Requirements and testing for shelf life determination
  • EN 1186: Materials and articles in contact with foodstuffs.


International Organization for Standardizations. ISO regularly publish standards which are audited for compliances by sanctioning organizations called “Notified bodies”. The relevant rubber medical glove standards are developed by the ISO Technical Committee TC 45, Sub Committee SC 4.

  • ISO 11193:2008 – Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution.
  • ISO 11193-2:2006 – Single-use medical examination gloves – Part 2: Specification for gloves made from poly(vinyl chloride).
  • ISO 10282:2002 – Single-use sterile rubber surgical gloves – Specification.
  • ISO 9001:2000 – Quality Management System of an organization.
  • ISO 13485:2003 – Quality management system for medical devices and related services.

Food Contact Regulation

Materials that come into contact with food must not contaminate food with hazardous substances. The Regulation 1935/2004/EC governs the requirements for traceability and identification throughout the production chain. The products shall also be marked with the glass/fork symbol.
The gloves shall be manufactured in accordance with Commission Regulation (EC) 20023/2006 on Good Manufacturing Practice (GMP) which imposes requirements on the manufacturer’s quality assurance system for articles intended to come into contact with food.
Protective gloves with glass/fork symbol meet the above requirements and can be used in contact with food. What kind of food they are adapted for is stated in the user instruction that accompany the glove.


ASTM for American Society for Testing and Materials. Non-profit organization that provides a forum for consumers, manufacturers, citizens, organizations, government representatives and academia, to meet and write standards for variety of products, services, and materials.
The FDA recognizes the ASTM standards and they are listed in the US Federal Register. Glove manufacturers must conform to the standards in order to meet the requirements by the FDA for the particular type(s) of medical gloves.