Indications 
Sterile powder-free nitrile surgical gloves are used as a biological barrier to protect the user's hands from contamination. Gloves are designed to come into contact with the patient and prevent cross-contamination between the patient and user.

Used materials 
Acrylonitrile-butadiene rubber, Stabilizer, Crosslinker, Antioxidant, Wax Emulsion, White pigment

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
• EU directive/regulation : REGLEMENT 2017/745
• annexe : IX

EPI 

• european directive(s) - regulation(s) : 2016/425
• 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
• Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• Protective gloves — General requirements and test methods
• Protective gloves against chemicals and micro-organisms - Part 2 : determination of resistance to penetration
• protective gloves against chemicals and micro-organisms - Part 4 : determination of resistance to degradation by chemicals
• 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 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.