The EN 455 series of Standards specifies the requirements that single-use gloves should meet to be used in medical applications, ensuring their safety and effectiveness for both patient and user. Compliance to the EN 455 Standards brings a presumption of conformity of the glove to the applicable Legislation in the EU (Medical Device Regulation (EU) 2017/745).

To comply with EN 455, gloves must pass different tests to ensure they act as a barrier against microorganisms, perform effectively without breaking, and are biologically safe for the healthcare and patient alike; all this throughout their entire shelf life. These tests include:

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  Freedom from Holes, which uses a water leak test that is carried out using AQL, a statistical sampling method.

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  Physical properties, where dimensions (length & width) and force at break before and after heat ageing are tested.

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  Biological Safety, which involves test procedures for measuring powder residues in powderfree gloves, leachable proteins in natural rubber latex gloves and possible endotoxin contamination of sterile gloves.

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  Shelf life Study, with a protocol to be followed to evaluate the gloves shelf life by using real time studies or a suitably validated alternative.

On 23rd September 2023, a new revision of EN 455-3:2015 was approved at EU level and subsequently endorsed by all EU Member States by 29th May 2024. Updates include:

• Introduction of a new pictogram and/or warning statement regarding the potential presence of Type IV chemical allergens on at least the dispenser box of the product.
• Manufacturers will be obliged to provide a list of chemical ingredients known to cause adverse health effects.
• A clarifying note has been added for optional Low Endotoxin claims.
• A note explaining that the use of powder-free gloves is strongly recommended is now included.

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