Medical examination gloves are used to protect staff and patients from contamination. They are considered a medical device and must therefore meet various quality requirements, such as the Medical Devices Regulation (MDR) and the European Standard EN 455-1 to 4.
Qualifications of medical examination gloves:
- Medical Devices Regulation (MDR).
European Regulation (EU) 2017/745 on medical devices. It is considered the most important regulation on the safety of medical devices in Europe and is internationally referred to as the Medical Devices Regulation (MDR).
- European Standard EN 455-1 to 4.
This standard qualifies medical gloves for single use. Extensive tests are required.
DIN EN 455-1: Requirements and testing for freedom from holes.
Freedom from holes is tested using the water impermeability test method. The AQL (Accepted Quality Level) is a measure for assessing statistical quality tests. In a precisely defined procedure, a certain subset of a total amount of gloves produced is made available for a random sample. The result can then be used to draw conclusions about the quality of the total amount. The EN 455-1 standard specifies an AQL of 1.5 for examination gloves.
DIN EN 455-2: Requirements and testing for physical properties.
This standard specifies the requirements and minimum dimensions and sizes as well as the testing of tear resistance for different glove materials.
DIN EN 455-3: Requirements and testing for biological evaluation (biocompatibility).
This standard provides information on manufacturing with regard to chemicals, endotoxins, powders and leachable latex proteins.
DIN EN 455-4: Requirements and testing for shelf life determination
The smallest packaging unit of medical gloves must be labelled with the shelf life of the gloves. This labelling must still be legible at the end of the shelf life. Furthermore, manufacturers must provide storage instructions to the end user. This can be a note on the packaging (e.g. pictograms for store dry and protect from heat). In addition, manufacturers of medical gloves must produce real-time studies for the shelf life of the gloves.