LATEX ANATOMICAL PROCEDURE GLOVES POLYSEM MEDICAL SINGLE USE STERILE SLEEVE PPE CAT III BOX OF 50 PAIRS

  • The Polysem Medical sterile latex procedure gloves meet the technical specifications for a latex surgical glove.
  • They are available in 1/2 sizes in order to adapt to the size of the operators' hands.
  • These gloves are rated as both a Class IIa medical device and Category III type B Personal Protective Equipment.

 

Description

Polysem Medical procedure gloves are indicated when the use of a sterile anatomical glove is required.

They can be used in emergency units, in care units (urinary catheterization, repair of dressings, etc.) and also for small surgery of very short duration.

Sterilization by gamma radiation.

The packaging in a dispenser box makes it very easy to take the pocket (folded format) two-sided paper-PE.

 

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. Main componant: Latex; these gloves must never been used by people (caregivers or patients) allergic to natural latex rubber protein. Latex - type I allergy. Moreover, these gloves are made with accelerators that may exceptionnally, cause 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.

Polysem Medical procedure gloves are indicated when the use of a sterile anatomical glove is required.

They can be used in emergency units, in care units (urinary catheterization, repair of dressings, etc.) and also for small surgery of very short duration.

Sterilization by gamma radiation.

The packaging in a dispenser box makes it very easy to take the pocket (folded format) two-sided paper-PE.

 

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. Main componant: Latex; these gloves must never been used by people (caregivers or patients) allergic to natural latex rubber protein. Latex - type I allergy. Moreover, these gloves are made with accelerators that may exceptionnally, cause 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.

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