BS EN 455 is the European standard for single use medical grade examination gloves. This standard is divided into 4 parts:

• EN 455-1 - Freedom from holes

Gloves must pass this test in order to prove that they are an effective barrier against micro-organisms.
 
Samples are taken from a batch of gloves and are subject to checks for pinholes and leaks. Medical grade gloves must achieve an acceptable quality level of 1.5 (AQL 1.5), this is the equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing micro-organisms to pass through.

• EN 455-2 – Physical properties

Medical grade gloves must meet certain dimensions and physical strengths. The requirements for physical properties depend on the glove type (Vinyl/Synthetic/Latex/Nitrile). Vinyl & Synthetic examination gloves must be able to withstand a force of 3.6 Newtons without breaking. When it comes to Latex and Nitrile examination gloves, they must be able to withstand a force of 6 Newtons without breaking. Whilst surgical gloves must meet a minimum of 9 Newtons.

• EN 455-3 – Requirements for biological evaluation

This standard includes tests for potentially hazardous materials that may affect the wearer or be transferred to a patient. These materials include endotoxins, latex proteins, chemical residues and powder. The standard also covers the limitations on product labelling.

• EN 455-4 – Requirements and testing for shelf life determination

This standard requires a set of tests to determine how long a glove will be fit for use. Ensuring that the glove meets the same standards at the start and end of their shelf life. The maximum shelf life that can be claimed for medical grade gloves is 5 years from the date of manufacture.

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