Personal Protective Equipment (PPE)
Personal Protective Equipment (PPE) is the legal umbrella term for all products worn or held by a person to protect against health and safety risks.
Legal basis: Regulation (EU) 2016/425 (PPE Regulation), fully applicable since 21 April 2018.
Categories:
- Category I: minimal risks (gardening gloves, light cleaning gloves)
- Category II: intermediate risks (mechanical gloves per EN 388)
- Category III: serious or irreversible risks (chemical protective gloves, FFP3)
PPE vs. medical device:
- PPE protects the wearer (PPE Regulation)
- Medical device primarily protects the patient (MDR)
- Chemotherapy gloves must comply with both frameworks simultaneously
Typical PPE categories for gloves:
- EN ISO 21420: general requirements (base standard)
- EN 388: mechanical protection (Cat. II)
- EN ISO 374-1 Type A/B/C: chemical protection (Cat. III)
- EN 16350: electrostatic protection (Cat. II)
- EN 407: heat protection (Cat. II or III)
- EN 511: cold protection (Cat. II)
All PPE must carry CE marking and the manufacturer must provide an EU Declaration of Conformity.
Frequently asked questions
What is the difference between PPE and a medical device?
PPE protects the wearer from workplace or environmental risks (PPE Regulation (EU) 2016/425). Medical devices serve medical purposes and primarily protect patients (MDR (EU) 2017/745). Some gloves must comply with both requirements.
What do PPE Categories I, II, and III mean?
Category I: minimal risks, manufacturer self-conformity assessment. Category II: intermediate risks, EU type-examination by Notified Body. Category III: serious/irreversible risks, Notified Body plus ongoing quality surveillance.