Used materials 
100% Nitrile (Acrylonitrile butadiene)

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

• MD class : IIa
• MD notified body : BSI CE2797
• annexe : IX

EPI 

• european directive(s) - regulation(s) : 2016/425 EU Regulation
• IPE category : III
• IPE notified body : BSI CE2797

sterile 

• sterile : yes
• sterilization method : gamma ray

conformity 

• Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
• Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
• Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
• Protective gloves — General requirements and test methods
• Protective gloves against dangerous chemicals and micro-organisms - Part 1 : Terminology and performance requirements for chemical risks.
• Protective gloves against dangerous chemicals and micro-organisms - Part 1 : Terminology and performance requirements for micro-organisms risks.