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 : I
• MD notified body : NA
• EU directive/regulation : 2017/745
• annexe : IV

EPI 

• european directive(s) - regulation(s) : 2016/425
• IPE category : III B
• IPE notified body : 0075

sterile 

• sterile : no

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
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• Medical Gloves - Résistance to Chemotherapy Drugs permeation
• Protective gloves — General requirements and test methods
• Protective gloves against chemicals and micro-organisms - Part 2 : determination of resistance to penetration
• Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 Bacteriophage
• Determination of material resistance to permation by chemicals - Part 1: permeation by liquid chemical under conditions of continuous contact
• Protective gloves against chemicals and micro-organisms - Part 4 : determination of resistance to degradation by chemicals
• 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.