Indications 
Hand protection during invasive procedures under image intensifiers in the operating room. These gloves reduce exposure to ionizing radiation during interventional radiological procedures.

Used materials 
Natural rubber latex

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 : 2797
• EU directive/regulation : 93/42/CEE-2007/47/CEE
• annexe : II

EPI 

• european directive(s) - regulation(s) : 2016/425
• IPE category : III
• IPE notified body : 2797

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
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• 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 2 : determination of resistance to penetration
• Protective gloves against chemicals and micro-organisms - Part 4 : determination of resistance to degradation by chemicals
• Protective gloves against ionizing radiation and radioactive contamination
• 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.