Description

Anatomical sterile latex gloves packaged in pairs in blister packs

Sterilised by eBeam (Beta electron beams)

Gloves perfectly suited for use in procedures requiring aseptic testing: minor intervention and surgery limited to one hour

Technical
information

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

Used materials 
Latex, vulcanisation accelerators

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 : 0123
  • EU directive/regulation : DIR 93-42, DIR 2007-47
  • annexe : II excluding (4)

sterile 

  • sterile : yes
  • sterilization method : beta decay

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

Anatomical sterile latex gloves packaged in pairs in blister packs

Sterilised by eBeam (Beta electron beams)

Gloves perfectly suited for use in procedures requiring aseptic testing: minor intervention and surgery limited to one hour

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

Used materials 
Latex, vulcanisation accelerators

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 : 0123
  • EU directive/regulation : DIR 93-42, DIR 2007-47
  • annexe : II excluding (4)

sterile 

  • sterile : yes
  • sterilization method : beta decay

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

Request for technical documentation

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