Developments In European Standards For Medical Gloves

This is a general overview of the legislation that governs the sale of medical gloves into the European Union including an explanation of the role that the manufacturer and the supplier are expected to play in certifying gloves to the Medical Devices Directive and a guide to the key Standards is provided. Finally a guide is given to future developments in the EN455 standards.

The regulations that affect the export of rubber gloves for medical use and the Standards that have been created to support them are constantly evolving. The aim of this evolution is the provision of ever better glove performance and levels of protection for the end user and the patients that they care for. Unfortunately this evolution can lead to confusion for the suppliers and manufacturers who are producing the product.

This paper aims to clarify the current situation with respect to which Standards and regulations apply to gloves as well as provide a guide to some of the changes to the Standards that are expected to occur during the next decade. Click here for details.

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