Indications 
Gynaecological examination, uterine examination.

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 : I
• MD notified body : 2797
• EU directive/regulation : 93/42/CEE - 2007/47/CEE
• annexe : V

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