# Nitrile gloves: medical device and PPE — classification | INOPREX

> Nitrile gloves can be both a medical device (examination glove under EU MDR) and personal protective equipment (PPE under Regulation (EU) 2016/425): classification, standards and labelling.

Quelle: https://inoporex.de/en/wissen/nitrilhandschuhe-medizinprodukt-psa/

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## 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.

Stand: 2026-10-22 · Fachlich verantwortlich: INOPREX Scientific Direction