EN 455 – the standard series for medical examination gloves
EN 455 is the European standard series that defines requirements for medical disposable gloves – both examination gloves and surgical gloves. The standard is harmonised under MDR 2017/745, meaning that CE marking as a medical device requires conformity with the relevant parts.
Structure of the standard series:
| Part | Title | Core content |
|---|---|---|
| EN 455-1 | Freedom from holes | Leak testing, AQL, water test |
| EN 455-2 | Physical properties | Dimensions, cuff length, force at break |
| EN 455-3 | Biological evaluation | Biocompatibility, allergy, protein content |
| EN 455-4 | Shelf life | Shelf life, accelerated ageing, real-time testing |
| EN 455-5 | Chemical substances | Accelerators, limit values, labelling requirements |
EN 455-1 – Tightness and AQL
The water test method
Leak testing is performed by filling the glove with 1,000 ml of water and observing for leakage. The test is standardised and simulates the glove's barrier integrity in use.
AQL – Acceptable Quality Level
AQL is the statistical method used to control the quality of gloves in production. It is not a test of an individual glove – it is a batch sampling inspection.
Understanding the AQL number:
AQL indicates the maximum percentage of defective units in a batch that is accepted in the long run.
| AQL | Application | Interpretation |
|---|---|---|
| AQL 0.65 | Surgical gloves | Most stringent – below 1 % defective |
| AQL 1.5 | Examination gloves | Standard for procedure gloves |
| AQL 2.5 | Rarely seen in medical use | Used in some industrial gloves |
Important: Lower AQL number = stricter quality control. A glove with AQL 0.65 is not necessarily vastly superior in practice compared to AQL 1.5 – but the production batch is subject to stricter statistical control.
Defect types in EN 455-1
- Critical defects: Holes that compromise the barrier
- Tested on samples from each lot/batch
- The manufacturer is responsible for maintaining AQL across production
What the sales person should know
Customers often ask "is the glove AQL 0.65 or 1.5?" without understanding what it really means. A good sales person can explain that AQL is a production quality parameter, not a measure of an individual glove's strength.
EN 455-2 – Physical properties
Dimensions and cuff length
EN 455-2 sets minimum requirements for:
- Cuff length: Minimum length measured from cuff edge to fingertip – ≥ 240 mm for examination gloves (all sizes), and size-dependent ≥ 260–285 mm for surgical gloves
- Width: Tolerance requirements per size (S, M, L, XL)
Cuff length is important to ensure sufficient coverage of the wrist and to avoid inadvertent contamination.
Force at break – force and elongation
Force at break is tested before and after artificial ageing:
| Parameter | Typical minimum requirement (examination) |
|---|---|
| Force at break (before ageing) | ≥ 6.0 N |
| Force at break (after ageing) | ≥ 4.0 N |
| Elongation at break (%) | ≥ 500 % (latex), ≥ 400 % (nitrile) |
Lower values after ageing are acceptable because materials degrade over time – but not below the minimum threshold.
Practical significance
Force at break is relevant for procedures with high mechanical load. A surgeon working with a scalpel and suture material needs a glove that will not tear under sudden force.
EN 455-3 – Biological evaluation
EN 455-3 (revised 2023) covers biological evaluation of gloves in contact with human skin and mucous membranes.
Biocompatibility (ISO 10993 series)
Gloves are assessed against the ISO 10993 framework:
- Cytotoxicity (ISO 10993-5)
- Sensitisation (ISO 10993-10)
- Irritation (ISO 10993-23)
Protein content in latex gloves
For latex gloves, EN 455-3 sets requirements for determining and declaring residual protein content (Hev b proteins):
- Tested with the modified Lowry method (described in EN 455-3 Annex A)
- Limit value: ≤ 50 µg/g water-soluble protein per gram of glove
- Manufacturers should state protein content to support risk assessment
Commercial perspective: The lower the protein content, the lower the allergy risk for latex-sensitised patients and personnel.
Information for the user
EN 455-3 requires the manufacturer to provide information on:
- Known sensitising substances
- Recommended precautions in case of allergy
- Relevant test results
EN 455-4 – Shelf life
What determines shelf life?
All rubber materials degrade over time – particularly under the influence of heat, UV light, ozone and moisture. EN 455-4 sets requirements for:
1. Accelerated ageing: Artificial simulation of time-based degradation at elevated temperature
2. Real-time testing: Actual storage and testing over the product's declared shelf life
3. Storage conditions: Temperature, humidity and UV exposure
Accelerated ageing
The method uses the Arrhenius principle: elevated temperature simulates natural ageing. 7 days at 70°C typically corresponds to ~2 years at 25°C (depending on the material and activation energy).
Shelf life on the packaging
The expiry date on the packaging is based on EN 455-4 testing combined with real-time data. The glove has been tested to meet all EN 455-1 and -2 requirements up to the expiry date under recommended storage conditions.
Practical advice for customers: Storing gloves in direct sunlight, hot warehouses or humid rooms invalidates the shelf life guarantee.
EN 455-5 – Chemical substances (published 2023)
EN 455-5 is the most recently added part and covers chemical substances that may be present in the finished glove from the manufacturing process.
Background: why was Part 5 needed?
Previously, EN 455 set no limit values for chemical residues from vulcanisation. Manufacturers could market gloves as "accelerator-free" without documenting it analytically. EN 455-5 closes this gap.
The most important accelerator groups
Thiurams:
- Tetramethylthiuram disulfide (TMTD)
- Tetramethylthiuram monosulfide (TMTM)
- Tetraethylthiuram disulfide (TETD)
Dithiocarbamates:
- Zinc diethyldithiocarbamate (ZDEC)
- Zinc dibutyldithiocarbamate (ZDBC)
- Zinc dibenzyldithiocarbamate (ZBEC)
Mercaptobenzothiazole (MBT) and derivatives:
- MBT, MBTS (dibenzothiazyl disulfide), CBS (cyclohexylbenzothiazyl sulfenamide)
Guanidines:
- Diphenylguanidine (DPG)
What does EN 455-5 establish?
1. Limit values for the listed substances in the extracted amount from the glove
2. Test methods: Typically solvent extraction followed by HPLC or LC-MS/MS analysis
3. Labelling requirements: The manufacturer must state:
- Whether accelerators are present above the threshold value
- Which accelerator groups have been used
- Whether the glove is "accelerator-free" and what this is based on
Accelerator-free documentation under EN 455-5
A glove can only be marketed as "accelerator-free" in conformity with EN 455-5 if:
- Analytical testing shows that the listed substances are below the limit values
- The documentation is available and up to date
Commercial point: EN 455-5 gives sales staff an objective basis for documenting accelerator-free claims – and gives buyers the ability to set specific requirements.
What customers should ask about
As a sales person/buyer you should be able to ask and answer:
- "Has the glove been tested in accordance with EN 455-5?"
- "Is there a test report documenting accelerator content?"
- "Which accelerators have been tested for, and are they below the limit value?"
- "Can you document accelerator-free status?"
How to read an EN 455 test certificate
A typical EN 455 test certificate from a testing institute contains:
1. Product identification: Name, size, batch number
2. Testing institute and accreditation: Must be an accredited laboratory (ISO 17025)
3. Test method reference: E.g. "Tested according to EN 455-1:2024"
4. Test results: Specific measurement results vs. requirements
5. Conclusion: Passed / not passed
6. Issue date and validity
Important: A test certificate applies to the tested product configuration. Changes in material composition or production process require new testing.
What the sales person should be able to explain
| Customer question | Sales person's answer |
|---|---|
| "What is AQL?" | Statistical batch quality parameter – lower number = stricter control |
| "What does EN 455 cover?" | Part 1: tightness, Part 2: strength, Part 3: bio-safety, Part 4: shelf life, Part 5: chemicals |
| "Is the glove accelerator-free?" | Ask for test report per EN 455-5 – it can now be documented analytically |
| "When does the glove expire?" | Shelf life per EN 455-4 under correct storage conditions |
| "Why is cuff length important?" | Covers the wrist and minimises leakage risk during procedures |