Product classification (according to applicable legislation):
Examination Glove - Class l (Regulation (EU) 2017/745 (DM)).
PPE glove - Category III (Regulation (EU) 2016/425 (PPE)).
Legal Requirements and Applicable Regulations:
Conformity to standards:
EN ISO 21420:2020- General requirements for protective gloves.
EN ISO 374-1:2016/A1:2018- Protective gloves against chemicals, glove type B.
EN ISO 374-5:2016- Protection against microorganisms and viruses.
UNE-EN 455 - 1,2,3,4 Disposable gloves for sanitary use.
ASTM D 6978-05 - Test for the evaluation of the resistance of medical gloves to permeation by chemotherapy drugs.
ASTM F 1670 - Blood penetration.
ISO 9001:2015 - Quality Management System in Distribution.
Class l, in accordance with the requirements of Regulation (EU) 2017/745 (DM).
Cat. lll, in accordance with the requirements of Regulation (EU) 2016/425 (PPE).