Knowledge · Nitrile gloves
Nitrile gloves: medical device and PPE
Examination gloves as medical devices under EU MDR — and at the same time as personal protective equipment.
Nitrile examination gloves are an example of dual regulation: as medical devices they protect patient and user in the medical context and fall under EU MDR (class I examination glove, IIa surgical). As personal protective equipment against chemicals or microorganisms they additionally fall under the PPE Regulation (EU) 2016/425.
Dual nature
| Aspect | Medical device (EU MDR) | PPE (Reg. (EU) 2016/425) |
|---|---|---|
| Purpose | Protection of patient and user in medical settings | Protection of the wearer at work |
| Class | Class I (examination), IIa (surgical) | Category I–III per risk |
| Standards | EN 455-1/2/3, ISO 13485 for QM | EN ISO 374, EN 388 per exposure |
| Marking | CE under MDR with UDI | CE with PPE category and performance levels |
Practical consequence
For a glove with dual purpose both frameworks must be met: MDR conformity including medical device marking and PPE conformity with testing, category and marking. The documentation routes run separately and must be consistent.
Frequently asked questions
Is every nitrile glove a medical device?
No — the intended purpose decides. A pure industrial glove without a medical claim is not a medical device. The “examination glove” is defined as a medical device.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.