Understanding EN 455‑2:2024 – physical properties
Part two governs how a glove fits and whether it holds: median dimensions per size and force at break per material, tested before and after ageing. What to require in a tender.
A glove that does not leak can still fail: too short at the cuff, too tight across the palm, or torn during donning. EN 455-2 is the part of the European medical glove standard that governs the physical properties – dimensions and strength – that decide whether a glove survives real use.
It applies to sterile, anatomically shaped surgical gloves and to examination and procedure gloves, sterile or not. For an overview of all five parts, start with our introduction to EN 455.
What changed in the 2024 edition
EN 455-2:2024 was approved by CEN on 15 April 2024 and supersedes EN 455-2:2015, which is withdrawn. Five changes were introduced:
A specification still citing "EN 455-2:2015" is therefore citing both a withdrawn document and one that cannot confer presumption of conformity under the MDR.
What the standard governs
Two requirement groups, plus the paperwork that proves them:
Dimensions
Thirteen gloves are taken from each lot, and the median value must meet the tabulated figures – not every individual glove. Length is measured by suspending the glove freely, middle finger downwards, against a vertical graduated rule with a rounded tip that matches the fingertip. Wrinkles and folds are removed without stretching. Width is measured to the nearest millimetre with the glove flat on a surface, again unstretched.
Surgical gloves
Examination and procedure gloves
The width requirements are written for natural rubber latex and other elastomeric materials, and the standard notes they may not be appropriate for gloves made from other materials. Manufacturers may optionally use the surgical size range for examination gloves where a finer range of sizes is wanted.
Force at break
Different materials need different minimum breaking forces to perform acceptably, so the standard sets values per material and glove type rather than one universal figure:
These are median values, and they apply throughout the shelf life when tested per clause 5.2, and within 12 months of manufacture when tested per clause 5.3. Testing is done at (23 ± 2) °C and (50 ± 10) % relative humidity on 13 dumb-bell test pieces cut from 13 gloves of a single lot – seven pairs where applicable – taken from the palm, back of the hand or cuff, avoiding textured areas, along the longitudinal axis. Test pieces are conditioned for at least 16 hours and pulled at a crosshead speed of 500 mm/min.
Challenge testing means seven days in an oven at (70 ± 2) °C, per ISO 188:2023 clause 5, before the force is measured again. That is what makes the requirement meaningful over a glove's shelf life rather than only on the day it was made.
The caution the 2024 edition adds is worth quoting in substance. Clause 5.1 now states that different glove materials require different force-at-break requirements to achieve acceptable performance, and that absolute force at break values do not directly correlate with in-use performance. Selecting the right material for the application is explicitly part of the risk management process.
That matters when comparing tenders. A nitrile glove at 7 N and a latex glove at 7 N are not equivalent in the hand, and a supplier presenting a higher force-at-break figure as evidence of a better glove is making an argument the standard itself declines to support. Elongation, modulus and thickness all bear on how a glove actually behaves – and note that EN 455-2 does not specify elongation at all. Where a datasheet quotes elongation figures, they come from another standard, usually the ASTM specification for that material.
Labelling
Clause 7 requires that the glove or its packaging carry the date of manufacture, in addition to the labelling requirements of EN ISO 15223-1:2021 and EN ISO 20417:2021. The standard defines date of manufacture as the packaging date, which is worth knowing when reconciling a shelf-life claim against a delivery.
Definitions that matter in a contract
The lot definition deserves attention in tendering. EN 455-2 does not cap lot size, but it flags the control problems that come with large lots and recommends a maximum of 500,000 units. A supplier declaring a single vast lot is declaring a single test result for a very large delivery.
Test report and labelling
A test report must state:
The material and the test-method deviations are both new emphases in the 2024 edition, and both are useful. A report that does not name the material cannot be read against the clause 5.1 caution above.
The date of manufacture – defined as the packaging date – must appear on the glove and/or its packaging. That date is what anchors the shelf-life claim under EN 455-4.
What to require in a tender
Our examination gloves are supplied with dimensional and physical-property data per size and independent pre-shipment inspection; the reports travel with the delivery.
Normative references
The 2024 edition draws on four documents, and the editions matter because the standard states that for dated references only the cited edition applies:
Note what is no longer there. The 2015 edition referenced EN 1041 for information supplied by the manufacturer; that has been replaced by EN ISO 20417:2021. A test report citing EN 1041, ISO 188:2007 or EN ISO 15223-1:2012 was produced against the withdrawn edition.
Key takeaways
The full standard can be purchased from BSI.
Frequently asked questions
Does EN 455-2 specify elongation? No. It specifies dimensions and force at break only. Elongation figures on a datasheet come from another standard, typically the ASTM specification for that material. A tender asking for "EN 455-2 elongation" is asking for something the standard does not define.
Why is a nitrile glove allowed a lower force at break than a surgical glove? Because the requirements are set per glove type and material, not as one universal figure. Surgical gloves must reach ≥ 9.0 N, examination gloves ≥ 6.0 N, and thermoplastic gloves such as PVC or PE ≥ 3.6 N. The 2024 edition also states explicitly that absolute force at break does not directly correlate with in-use performance.
Our supplier's report cites EN 455-2:2015. Is it still acceptable? The 2015 edition is withdrawn, and it is not harmonised under the MDR. The test itself may be substantially the same, but the report does not support presumption of conformity with Regulation (EU) 2017/745. Ask for testing against EN 455-2:2024.
What counts as a lot, and does lot size matter? A lot is gloves of the same design, colour, shape, size and formulation, made at essentially the same time by the same process from raw materials of the same specification, on common equipment, and packed in the same container type. The standard does not cap lot size but recommends a maximum of 500,000 units, noting the control difficulties of very large lots. One lot means one set of test results, so a very large declared lot is a thin evidence base for a large delivery.
Is the date on the box the date the gloves were made? EN 455-2 defines date of manufacture as the packaging date. Shelf life runs from it, which is worth confirming when reconciling a delivery against a shelf-life claim.
Seventeen years sourcing and supplying medical gloves and PPE to governments, UN agencies, NGOs and healthcare systems. Writes on glove standards, quality management and responsible sourcing for institutional buyers, working from the source standards rather than secondary summaries.
View profile on LinkedIn
