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

easyCARE latex PF powder-free disposable latex gloves - 100 pcs.
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: natural rubber latex
- Color: White/Cream
- Dust-free
- polymer-coated inner 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 62366-1:2015/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