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.
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.
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.
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.
