Testing standard
Medical gloves for single use — Part 2: Requirements and testing for physical properties
Written and technically reviewed by Dak System Inc. engineeringLast reviewed
EN 455-2 is the European standard setting the physical property requirements for single-use medical gloves, and it contains its own tensile method rather than calling one up. A dumb-bell is cut from each of thirteen gloves in a lot and pulled to break at 500 mm/min, and the median force at break must reach 9.0 N for surgical gloves, 6.0 N for elastomer examination gloves and 3.6 N for thermoplastic ones. The same thresholds apply after seven days of accelerated ageing at 70 °C.
EN 455-2 is a requirements standard that carries its own test method rather than pointing at one, which surprises people who expect a tensile procedure to be delegated. There is no reference to ISO 37, ASTM D412 or any other tensile standard in it. Its complete normative reference list is EN 455-4, EN 1041, EN ISO 15223-1, ISO 188 and ISO 23529, and the last two are called up only for the ageing oven and for thickness measurement.
The test is simple. A dumb-bell is cut from the glove, pulled to destruction, and the force at break recorded. Thirteen gloves are taken per lot, one dumb-bell from each, and the acceptance figure is the median of the thirteen — not the mean, and not the lowest.
Force at break is the property, and the standard names three categories rather than two. Surgical gloves must reach at least 9.0 N. Examination and procedure gloves in elastomer — latex, nitrile and the rest — must reach 6.0 N. Those made from thermoplastic materials, polyvinyl chloride and polyethylene, the gloves usually sold as vinyl, must reach 3.6 N.
The point most often got wrong is ageing. A single row of the requirement table covers both conditions: the same thresholds apply throughout shelf life on unaged gloves and, within twelve months of manufacture, after the ageing challenge. There is no relaxed post-ageing figure. A vinyl glove below 3.6 N after seven days in the oven has failed, not merely degraded.
The standard is also candid about what its own number means. Different glove materials need different force at break requirements, it says, and absolute force at break values do not directly correlate with in-use performance. Choosing a material for an application is part of risk management, not something the 9.0 N figure settles.
Thirteen gloves, one dumb-bell each, and a median. The statistic is as much a part of the requirement as the force is.
The standard sets the speed itself. It is fast for a specimen that breaks at a few newtons, which shifts the difficulty from the frame to the electronics.
A test piece that breaks at the shoulder does not need to be repeated — the standard says so explicitly, which is the opposite of most tensile methods. That result stays in the set of thirteen. Discarding low shoulder-break values raises the median and can turn a failing lot into a passing one.
Thin elastomer film is the awkward case the standard leaves to judgement. Pneumatic closure applies an even, repeatable clamping pressure across the tab, which is what keeps a glove dumb-bell from either slipping or tearing along the jaw line.
Specifications
Force here is measured in single newtons, so the frame is chosen for its load cell rather than its capacity. Pneumatic grips remove the operator variability that hand-tightened jaws introduce on a specimen this delicate.
SpecificationsCapacity is almost irrelevant and resolution is everything. The thresholds run from 3.6 to 9.0 N, so a load cell measured in tens of newtons is the right instrument, not a large frame working at the bottom of its range. The standard asks only for a load cell appropriate for the strength of the sample under test, and gives no accuracy class or capacity.
The crosshead speed is 500 mm/min, which is fast. On a specimen breaking at a few newtons the data acquisition rate and the dynamic response of the load cell matter far more than the frame does, and a slow sampling rate will miss the peak.
Grips are specified by what they must achieve rather than by type: jaws that firmly grip but do not damage the test specimen, with no grip design named at all. That is a genuine gap a laboratory closes with judgement, because thin elastomer film slips in flat jaws and tears at the jaw line when over-clamped.
EN 455-2 handles the jaw-break problem in a way that is the opposite of most tensile standards, and this is the single most useful sentence in its test clause: if a test piece breaks at the shoulder, it is not necessary to repeat the test on another test piece.
That has a consequence people miss. Because the acceptance figure is the median of thirteen, and because a shoulder break is a valid result, a low shoulder-break value cannot be quietly discarded. Doing so shifts the median upward and turns a failing lot into a passing one. The standard has decided that a glove that breaks at the shoulder is a glove that broke.
The second recurring error is expecting a lower requirement for aged gloves. There is not one.
The third is quoting an AQL for Part 2. Part 2 contains none.
Table 3 of EN 455-2:2015, reproduced in full. Note that it is a single row: one set of thresholds serves both the unaged and the aged condition.
| Condition | Surgical gloves | Examination or procedure, elastomer | Examination or procedure, thermoplastic |
|---|---|---|---|
| Throughout shelf life, unaged; AND within 12 months of manufacture after the ageing challenge | ≥ 9.0 N | ≥ 6.0 N | ≥ 3.6 N |
There is no relaxed post-ageing figure — this is the most misreported thing about EN 455-2. The elastomer column covers all examination gloves EXCEPT those made from thermoplastic materials; the thermoplastic column covers polyvinyl chloride and polyethylene, the gloves usually sold as vinyl. The standard also warns in clause 5.1 that absolute force at break values do not directly correlate with in-use performance, and that selecting an appropriate material is part of risk management.
| Part | Covers |
|---|---|
| Part 1 | Requirements and testing for freedom from holes — this is where the AQL lives |
| Part 2 | Requirements and testing for physical properties — dimensions and force at break |
| Part 3 | Requirements and testing for biological evaluation |
| Part 4 | Requirements and testing for shelf life determination |
Part 2 references Part 4 rather than duplicating it: ageing and shelf life requirements are described in EN 455-4, while Part 2 only carries the seven-day oven challenge used to demonstrate force at break. An AQL quoted against Part 2 is a Part 1 figure that has drifted.
It is Part 2 of the European standard for single-use medical gloves, covering requirements and testing for physical properties — chiefly dimensions and force at break. The current edition is EN 455-2:2024, harmonised under the European medical devices regulation. Unusually for a requirements standard, it contains its own tensile test method rather than calling one up.
No. There is no reference to ISO 37, to ASTM D412 or to any other tensile method anywhere in it. Clause 5.2 defines the test itself, including a dimensioned dumb-bell cutter, the crosshead speed and the sampling. Its complete normative reference list is EN 455-4, EN 1041, EN ISO 15223-1, ISO 188 and ISO 23529, and the last two are used only for the ageing oven and for thickness measurement.
It depends on the category, and there are three rather than two. Surgical gloves must reach at least 9.0 N. Examination and procedure gloves made from elastomer — latex, nitrile and the like — must reach at least 6.0 N. Examination and procedure gloves made from thermoplastic materials such as polyvinyl chloride and polyethylene, usually sold as vinyl, must reach at least 3.6 N. The figure is the median of thirteen specimens.
No, and this is the point most often got wrong. Table 3 is a single row that covers both conditions: the same 9.0, 6.0 and 3.6 N thresholds apply throughout shelf life on unaged gloves and, within twelve months of manufacture, after the ageing challenge of seven days at 70 °C. A glove that falls below its threshold after ageing has failed.
Because the standard says so: the force at break is recorded for each of the thirteen specimens and the median of those results must comply with Table 3. A median is insensitive to one extreme value in either direction, which suits a test where a shoulder break is an accepted outcome rather than a reason to retest. It also means the acceptance decision cannot be rescued by one unusually strong specimen.
No. EN 455-2 states plainly that if a test piece breaks at the shoulder it is not necessary to repeat the test on another test piece. That is the opposite of most tensile standards and it has a consequence worth being careful about: because acceptance is the median of thirteen, a low shoulder-break value must stay in the set. Discarding it shifts the median upward and can turn a failing lot into a passing one.
The standard does not say. It states the functional requirement — jaws that firmly grip but do not damage the test specimen — and names no grip type, pressure or face material. That leaves a real decision to the laboratory, because thin elastomer film slips out of flat jaws if under-clamped and tears along the jaw line if over-clamped. Pneumatic grips help by applying an even, repeatable pressure that does not vary with the operator.
Very little, and that is the trap. The thresholds run from 3.6 to 9.0 N, so a load cell of a few tens of newtons is the right instrument and a large frame working at the bottom of its range is not. The standard asks only for a load cell appropriate for the strength of the sample under test and gives no capacity or accuracy class. The crosshead speed of 500 mm/min is fast for a specimen that breaks at a few newtons, so data acquisition rate and load cell dynamic response matter more than the frame.
None. The words acceptable quality level do not appear in Part 2 at all. The AQL of 1.5 that is widely quoted in connection with medical gloves belongs to EN 455-1, which covers freedom from holes and uses a watertight test. Attributing an AQL to Part 2 is a common mix-up between the parts.
EN 455 has four parts under one general title. Part 1 covers freedom from holes, Part 2 physical properties, Part 3 biological evaluation and Part 4 shelf life determination, and Part 4 is where ageing and shelf life requirements are actually described. ISO 188 supplies the ageing oven and ISO 23529 the thickness measurement. EN 1041 and EN ISO 15223-1 govern the information and symbols supplied with the device. ASTM D3578 for rubber examination gloves and ASTM D6319 for nitrile examination gloves are the American counterparts; those texts were not retrieved and no comparison of their figures is offered here.
Dak verifies against whichever standard the method names, and where a class applies our frames sit a class tighter than it asks.
| The method asks for | Dak supplies | |
|---|---|---|
| Capacity | Very low. The requirement is 9.0 N for surgical gloves, 6.0 N for elastomer examination gloves and 3.6 N for thermoplastic ones, so a load cell of a few tens of newtons is the right instrument rather than a large frame. | Load cells from 1 kg to 60 ton on the Series 7200, and 0.5 to 100 kN on the Series 9000 |
| Force accuracy | none stated — the standard asks only for a load cell appropriate for the strength of the sample under test and gives no class | ISO 7500-1 Class 0.5, verified to ASTM E4, DIN 51221 and BS 1610 |
| Gripping | Jaws that firmly grip but do not damage the test specimen. The standard names no grip type at all, which leaves the choice to the laboratory; thin elastomer film slips in flat jaws and tears at the jaw line when over-clamped. | Wedge, vice-action, pneumatic and hydraulic grips, built to the specimen |
| Environment | Conditioning for at least 16 hours before test. Ageing, where it applies, is 7 days at 70 plus or minus 2 degrees Celsius in an oven specified by ISO 188. | 3009 series chambers, −150 °C to +400 °C — temperature only |
This page describes the method as practised. The governing text is the current edition from the issuing body. Tell us what you are testing and we will answer with the machine, the fixture and a quotation.
