PPE – what it is and why it differs from medical devices
PPE (Personal Protective Equipment) is equipment designed to protect the user against hazards. Unlike medical devices (which primarily protect the patient), PPE is user-oriented.
PPE gloves are regulated by EU PPE Regulation 2016/425 – applicable from April 2019 and replacing the former PPE Directive 89/686/EEC.
The three PPE categories
The PPE Regulation divides equipment into three categories based on risk level:
| Category | Risk level | Typical gloves | CE requirements |
|---|---|---|---|
| I | Low – superficial damage | Light mechanical protection, gardeners | Manufacturer self-certification |
| II | Medium-high | Mechanical protection at moderate risk, some anti-vibration and heat gloves | EU type examination (notified body) |
| III | High – irreversible damage or life-threatening risk | Chemical-resistant gloves (EN ISO 374 Type A/B/C), biological hazard, cytostatics | Type examination + ongoing production control (NB) |
Key point for gloves:
All chemical-resistant gloves certified under EN ISO 374 are Category III – regardless of whether they are Type A, B or C. Chemical exposure that can cause irreversible health damage is by definition a Category III risk. A notified body is mandatory.
EN ISO 21420:2020 – base standard for protective gloves
EN ISO 21420:2020 (replacing EN 420:2003) is the base standard that all PPE gloves must meet, regardless of the specific hazard type.
Requirements under EN ISO 21420:
- Design and construction: The glove must not itself constitute a hazard – no sharp edges, protrusions or harmful materials
- Innocuousness: The glove must not contain known allergenic substances above limit values
- Comfort and efficacy: Requirements for ergonomics, tactile sensitivity and ability to handle objects
- Marking: Clear marking with size, relevant pictograms and standard references
- Information for the user: Instructions for use including correct use, limitations and storage
EN ISO 21420 is a mandatory background requirement – no EN ISO 374 certification is valid without EN ISO 21420 being met.
EN ISO 374-1 – chemical resistance and classification
EN ISO 374-1 sets requirements for performance and classification for chemical-resistant gloves.
Test method: permeation test
The permeation test measures how quickly a chemical penetrates through the glove material at molecular level – without visible holes.
Three stages:
1. The chemical is applied to the outer surface of the glove
2. The inner surface is monitored with a sensor
3. Breakthrough time is recorded
Breakthrough time = time from the chemical being applied until it is detected on the other side at a specific concentration.
Type A, B and C classification
| Type | Minimum number of chemicals | Minimum breakthrough time |
|---|---|---|
| Type A | 6 chemicals | ≥ 30 minutes for all 6 (Performance Level 2) |
| Type B | 3 chemicals | ≥ 30 minutes for all 3 (Performance Level 2) |
| Type C | 1 chemical | ≥ 10 minutes (Performance Level 1) |
Performance Levels for breakthrough time:
| Level | Breakthrough time |
|---|---|
| 1 | ≥ 10 minutes |
| 2 | ≥ 30 minutes |
| 3 | ≥ 60 minutes |
| 4 | ≥ 120 minutes |
| 5 | ≥ 240 minutes |
| 6 | ≥ 480 minutes |
Chemical designations
EN ISO 374-1:2016+A1:2018 uses a standardised list of 18 reference chemicals designated with letters A–R:
| Code | Chemical |
|---|---|
| A | Methanol |
| B | Acetone |
| C | Acetonitrile |
| D | Dichloromethane |
| E | Carbon disulfide |
| F | Toluene |
| G | Diethylamine |
| H | Tetrahydrofuran |
| I | Ethyl acetate |
| J | n-Heptane |
| K | Sodium hydroxide 40 % |
| L | Sulphuric acid 96 % |
| M | Nitric acid 65 % |
| N | Acetic acid 99 % |
| O | Ammonia 25 % |
| P | Hydrogen peroxide 30 % |
| Q | Hydrofluoric acid 40 % |
| R | Formaldehyde 37 % |
On the packaging and in documentation, the pictogram shows the letter codes for the tested chemicals and the performance levels achieved for each.
EN ISO 374-2 – penetration test
While the permeation test measures molecular penetration, the penetration test measures visible leakage through holes, cracks and seams.
Method: Air pressure and water leakage test analogous to the AQL principle in EN 455-1, adapted for PPE context.
When is it relevant?
Penetration testing is relevant for biological agents (bacteria, fungi, viruses) that do not permeate at molecular level but can leak through physical defects.
EN ISO 374-4 – degradation
Degradation is the material's physical deterioration through chemical contact – without the chemical necessarily having penetrated through.
Test: The glove material is exposed to the chemical and changes in force at break, elongation and thickness are measured.
Practical relevance:
A glove that degrades rapidly loses its structural integrity and may burst. Degradation curves are useful to review, even though they are not the primary measure of chemical resistance.
EN ISO 374-5 – micro-organisms and VIRUS claim
EN ISO 374-5 sets requirements for gloves that protect against biological agents:
Two levels:
- Basic (bacteria and fungi): Penetration test per EN 374-2 with AQL ≤ 1.5 required
- VIRUS claim: Additional requirement to pass a virus penetration test
The virus penetration test (ISO 16604)
The test uses bacteriophage Phi-X174 as a model virus particle (approx. 27 nm – a conservative measure) under hydrostatic pressure.
To carry the VIRUS pictogram on the glove:
- The glove must pass ISO 16604 (virus test)
- Test results must be documented in the technical file
Commercial relevance:
The VIRUS claim is relevant for healthcare workers handling potentially virus-containing material – including HIV, hepatitis B and C. Typically required in the hospital sector for blood exposure situations.
How to read a chemical resistance table
Suppliers typically provide chemical resistance tables showing test results per chemical and performance level.
Example table format:
| Chemical | Permeation time (min) | Performance Level |
|---|---|---|
| Methanol (A) | 45 | PL 2 |
| Acetone (B) | 5 | PL 1 |
| Toluene (F) | 180 | PL 4 |
What to note:
- Acetone breaks through quickly (low level) – if the glove is used for acetone exposure, it is not suitable
- Test temperature and conditions may differ from real working conditions
- Thickness affects results – thinner gloves = shorter breakthrough time
Breakthrough time and safety margin
Breakthrough time is not an absolute limit – it is a laboratory result under standardised conditions.
In real working situations there are factors that reduce the actual protection time:
- Elevated temperature (accelerates permeation)
- Mechanical stretch and friction
- Combined chemical exposures
- The glove is not new (degradation from storage)
Safety margin principle:
Use at most 50–75 % of the tested breakthrough time as a guideline for glove change intervals. A test result of 60 minutes → recommend changing after at most 30–45 minutes.
Notified body – when is it required?
| Situation | NB required? |
|---|---|
| Category I PPE | No |
| Category II PPE (e.g. mechanical protection, heat gloves) | Yes – type examination |
| Category III PPE (incl. all EN ISO 374 chemical gloves) | Yes – type examination + periodic audit |
| Medical device Class I | No (except sterile) |
| Medical device Class I sterile | Yes – sterilisation aspect |
Practical consequence for procurement:
All chemical-resistant gloves (EN ISO 374 Type A, B and C) are Category III. The supplier must be able to present a valid certificate from an accredited notified body. Without this, the CE mark is not lawful and the glove should not be purchased.