These are disposable non-sterile examination and protective gloves, intended for use in the medical field and covering other areas such as certain food and chemicals and for: protecting patient and user from cross-contamination, carrying out medical examinations, diagnostic and therapeutic procedures and for handling medically contaminated material. Gloves are classified as medical devices class I and as personal protective equipment category III. Gloves designed to protect against substances and mixtures hazardous to harmful biological agents. Gloves designed to protect against chemical risk according to EN ISO 374-1 and microorganisms (viruses, bacteria and fungi) according to EN ISO 374-5. Their design and labeling correspond to the requirements of the EU Regulation 2017/745 on medical devices and the European Regulation 2016/425 on personal protective equipment. Gloves should only be used in accordance with their intended use.
MD Class I: EU Regulation 2017/745(MDR), EN 455-1,2,3,4
PPE Cat.III: EU Regulation 2016/425(PPER), EN 374-1,2,4,5 EN14683-1, EN ISO 21420.
Food contact: EC Regulation 10/2011, EN 1186 and EN 13130