easyCARE vinyl PF powder-free disposable vinyl gloves - 100 pcs.

easyCARE vinyl PF vinyl glove, non-sterile, non-powdered for sensitive skin.
Low thickness, high level of protection and excellent elasticity.

The device is intended for patient diagnostics, providing a barrier to the transmission of microorganisms between operator and patient, minimizing the risk of cross-contamination

- Class I Medical Device, Category III Personal Protective Equipment
- Raw material: polyvinyl chloride
- Color: Transparent white
- Dust-free
- smooth outer surface
- AQL 1.5
- beaded cuff
-ambidextrous

- allowed to come into contact with food: in accordance with Regulation (EC) 1935/2004 and Commission Regulation (EC) 10/2011
- Quality assurance system: production process in accordance with EN ISO 9001 and EN ISO 13485

Classification:
- Class I medical device compliant with the Medical Device Regulation (EU) 2017/745 (MDR)
- Category III personal protective equipment according to PPE Regulation (EU) 2016/425

Compliance with standards:
EN 455-1:2020, 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 62366-1:2015+EN 623661:2015/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 420:2003+A1:2009, EN ISO 374-1:2016+A1:2018, EN 374-2:2014, EN 16523-1:2015+A1:2018, EN 374-4:2013, EN ISO 374-5:2016