STERILE POWDER-FREE LATEX SURGICAL GLOVES POLYSEM MEDICAL

  • Anatomical latex sterile glove
  • Powder-free
  • Available in half-sizes to adapt to every operator's hand size
  • Two regulatory statuses: Class IIa Medical Device and Category III - Type B Personal Protective Equipment

Description

Anatomical sterile latex gloves, packaged in pairs in blister packs.
Gamma-ray sterilized.
Perfectly suited for use in aseptic procedures: small operations and surgeries limited to one hour.
Available in all half-sizes from 5.5 to 9.0 to fit the operator's hands as closely as possible.
The dispenser box makes it easy to grasp the two-sided paper-PE pouch (folded format).

Depending on size, cuff length varies between 278mm and 290mm.

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 patient and user. Intervention gloves for short surgical procedures and procedures requiring sterile gloves (urinary catheterization, dressing repairs, etc.). Main component Latex; these gloves must under no circumstances be used by people (caregivers or patients) allergic to latex proteins - Type I allergy. In addition, these gloves contain vulcanization gas pedals which can exceptionally lead to type IV allergies.

Used materials 
Naturel Rubber 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 : BSI - CE 2797
  • EU directive/regulation : MDR 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
  • 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.

Anatomical sterile latex gloves, packaged in pairs in blister packs.
Gamma-ray sterilized.
Perfectly suited for use in aseptic procedures: small operations and surgeries limited to one hour.
Available in all half-sizes from 5.5 to 9.0 to fit the operator's hands as closely as possible.
The dispenser box makes it easy to grasp the two-sided paper-PE pouch (folded format).

Depending on size, cuff length varies between 278mm and 290mm.

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 patient and user. Intervention gloves for short surgical procedures and procedures requiring sterile gloves (urinary catheterization, dressing repairs, etc.). Main component Latex; these gloves must under no circumstances be used by people (caregivers or patients) allergic to latex proteins - Type I allergy. In addition, these gloves contain vulcanization gas pedals which can exceptionally lead to type IV allergies.

Used materials 
Naturel Rubber 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 : BSI - CE 2797
  • EU directive/regulation : MDR 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
  • 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.

Request for technical documentation

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