EN 455 PROTECTIVE GLOVES
Medical Gloves for Single Use
EN 455 are single use gloves which comply with a number of requirements so both the wearer and patient on the receiving end are safe. For a glove to pass EN 455 it must pass 4 requirements until it is safe to be used for any work. If you have any questions regarding EN 455 gloves and their requirements, please do not hesitate to contact a member of the team who will advise you and help you fulfill your next protective glove order.
Requirements and testing of gloves for freedom from holes
Each batch of gloves are tested by filling with water. If the gloves can hold the liquid without any leaks then it has safety passed Part 1. Gloves must achieve an acceptable quality levels (AQL) of 1.5 or better in order to be acceptable for any work carried out.
The Acceptable Quality Level (AQL) is an internationally recognised quality standard which assesses the statistical quality control of products including medical protective gloves. An AQL result of 1.5 means that there are less than 1.5% of the products with defects in the batch of gloves. It is important to remember that the lower the AQL number rating, the greater the quality of barrier protection the user will have.
Requirements and testing of gloves for physical properties
This includes tests for glove dimensions and physical strength. Medical gloves need to be stronger than they look so part 2 requires a test which pushes a force on the glove to measure when it will break. However, obviously there are different expectations of gloves which have different purposes. For example, surgical gloves will require higher pass rates for strength than examination gloves. The withstood force needed to pass is as follows:
Force needed to break surgical gloves - 9.0 (Newtons)
Force needed to break gloves made of rubber (e.g. latex) - 6.0 (Newtons)
Force needed to break gloves made of thermoplastics (e.g. vinyl) - 3.6 (Newtons)
Requirements and testing of gloves for biological evaluation
The materials the gloves are made from must be proved to NOT be harmful to the wearer or patient as both an immediate reaction or a slower reaction. Gloves are manufactured with various chemicals, powders, irritants and plastics which may cause you harm which is why part 3 ensures you are protected.
The gloves are tested in 4 different parts within this area to ensure you will not develop any skin irritations.
Chemical residues - This test discovers the level of chemicals left on the glove from the manufacturer
Latex - This test discovers the latex protein levels on the glove
Powder - Powered gloves are proven to cause skin irritations so this test is carried out to ensure the product meets the correct specifications to be powder-free. A glove which has a powder level which exceeds 2mg/glove is considered enough to be a powdered glove
Endotoxin - (For sterile gloves) The endotoxin must be checked to ensure illnesses such as fever are prevented. For a glove to pass as low endotoxin, the level must be below 20EU/pair of gloves (EU = Endotoxin Units).
Requirements and testing of gloves for shelf life determination
The final part of the test is to prove the gloves degrade in performance while in transit, stored in warehouses or awaiting use for it's final purpose. EN 455 gloves can only ever be stored up to 5 years from their manufacturing date. You will often see gloves with best-before dates stated on their packaging to ensure the performance of the gloves and safety of the wearer is not compromised.