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Produktsicherheitsverordnung
The General Product Safety Regulation (EU) 2023/988, known internationally as the GPSR, has governed the general safety of consumer products in the EU since 13 December 2024. It replaces the General Product Safety Directive 2001/95/EC and applies directly in all Member States. For medical devices and PPE, the sector-specific frameworks MDR and the PPE Regulation take precedence; the GPSR applies in addition.
EN 13034
EN 13034 sets requirements for protective clothing with limited performance against liquid chemicals, known as Type 6. It protects against light spray mist and small splashes, not against pressurised jets or full liquid tightness. Type 6 is the lowest level of chemical protective clothing.
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Nitrile
Nitrile (Nitrile Butadiene Rubber, NBR) is a synthetic rubber used as the primary material for latex-free protective and examination gloves. Nitrile gloves offer good resistance to oils, fats, solvents, and many chemicals. Nitrile is latex-free but typically contains vulcanisation accelerators.
Manufacturer
Manufacturer is the natural or legal person who develops, manufactures, or as the responsible person markets a medical device under their own name. Under MDR (EU) 2017/745, the manufacturer bears responsibility for product conformity and is required to maintain a quality management system.