SeraMed Nitrile gloves laboratory medicine food super light weight are suitable for both the food industry and the medical sector. The disposable gloves are made from a soft, skin-friendly material and are powder-free and offer particularly high wearing comfort and have optimal allergy-friendly protection. 1) Medical Device Regulation (MDR). This product is classified as a Class I medical device according to Rule 5 (1) of Annex VIII and complies with the provisions of the Medical Devices Regulation (EU) 2017/745. This product complies with European standards DIN EN 455-1:2020-07, EN 455- 2:2015, EN 455-3:2015 and EN 455-442009 2) Regulation on Personal Protective Equipment (PPE). a) This product is in accordance with the PPE Regulation (EU) 2016/425 as personal protective equipment(PS) A) category III and has been proven to comply with the requirements of this regulation in accordance with the harmonised European standards EN ISO 21420:2020-06, EN ISO 374-1:2016+A1:2018 and EN ISO 374- 5:2016. b) The responsible for certification and compliance with Module B. NNNNNNNRA Technology Europe Limited (2777), Bracetown Business Park, Clonee, Dublin 15, D15 YN2P, Ireland. c) The notified body responsible for internal production control and supervised product testing at irregular intervals (Module (2) is SATRA Technology Europe Limited (2777), Bracetown Business Park, Clonee, Dublin 15, D15 YN2P. Ireland 3) Declaration of conformity The EU declaration of conformity (MDR and PSA) 4) Indication for use (IFU) A powder-free nitrile examination glove is a disposable nitrile rubber glove worn on the hand for medical purposes to form a barrier against potentially infectious materials and other contaminants. In addition, this product has the potential risk of user awareness to chemical...