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STANDARDIZATION AND NORMS UPDATE FOR EN 455-3:2023

Joshua Stevens
Joshua Stevens
Glove manufacturing process with the European Union flag symbolizing compliance with EU standards for safety and quality.

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:


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

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

  • 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.

  • 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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