Indications
Procedures requiring a sterile glove.
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.