Medical Devices Directive
The Medical Devices Directive 93/42/EEC classifies devices according to the potential hazards related to their use, the expected duration of contact with a patient and the expected invasiveness of their use.

If a glove is deemed to conform to the Medical Devices Directive it must carry a CE mark on its packaging, and may also provide a statement of its classification. In addition, the properties of medical devices are described by a range of standards to which the devices must conform. End-users are expected to use a risk assessment process to identify which gloves are suitable for the tasks they are conducting.

Classification of Devices
Class I
Non-invasive devices, for example examination gloves (entry into a bodily orifice is not considered invasive).

Class I Sterile
Sterilised class I devices, for example sterile procedure gloves.

Class I Measuring
Class I devices that perform a measurement, for example a thermometer.

Class IIa
These are short term invasive devices, for example examination gloves.

Class IIb
Gloves do not fall within this category. Examples of products that do, are devices that are intended to have a biological effect or be in place for long periods of use.

Class III
Gloves do not fall within this category. Products that are included are pacemakers and devices which come in to direct contact with the central nervous system.

European Standard for Medical Gloves
EN455-1 – Freedom from holes
This standard specifies the acceptable quality level (AQL) for holes. The acceptable quality level defines the permissible chance that a hole will be present in a glove.

EN455-2 – Physical properties
This standard specifies the physical dimensions of a glove (its size) and the minimum force at break that it must possess.

EN455-3 – Requirements for biocompatibility and labelling
This standard addresses such issues as allergic reaction to glove materials, permissible endotoxins content, the duty to disclose certain information to the end-user and the wording and symbols to be used on packaging.