Hansker easyCARE nitrile ROSA M

CLASSIFICATION Class I medical device compliant with Medical Devices Regulation (EU) 2017/745 (MDR) Personal Protective Equipment Category III according to PPE Regulation (EU) 2016/425 INTENDED PURPOSE  the device is intended for patient diagnostics, providing a barrier to the transmission of microorganisms between the operator and the patient, minimizing the risk of cross-contamination FEATURES  raw material: 100% nitrile (acrylonitrile butadiene)  colour: black  cuff: beaded  powder: powder free, the content of powder residue below 2mg per glove  AQL: 1,0  internal surface: chlorinated  outer surface: micro-textured throughout the glove with additional texturing at the fingertips  compliance with the standards: EN 455-1:2020 + A1:2022, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009, EN ISO 13485:2016 + EN ISO 13485:2016/A11:2021, EN ISO 14971:2019 + EN ISO 14971:2019/ A11:2021, EN 623661:2015 + EN 62366-:2015/ A1:2020, EN ISO 15223-1:2021, EN ISO 20417:2021, EN ISO 10993-1:2020, EN ISO 10993-5:2009, EN ISO 10993-10:2013, EN ISO 11737-1:2018 + EN ISO 117371:208/A1:2021, EN ISO 374-1:2016 + EN ISO 374-1:2016/ A1:2018, EN 374-2:2014, EN ISO 21420:2020, EN 165231:2015 + A1:2018, EN ISO 374-4:2019, EN ISO 374-5:2016, ASTM 1671, ASTM D6978  allowed for contact with food: in accordance with Regulation (EC) 1935/2004 and Commission Regulation (EC) 10/2011  quality assurance system: manufacturing process in accordance with EN ISO 9001 and EN ISO 13485  intermediate packaging: 100 pcs with a colour-coded packaging for easy size recognition  size: XS-XL  single-use  non-sterile  shelf life: 5 years