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polysem medical
polysem medical
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EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 290MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 UNITS

Reference : GN290
size 

  • Non-sterile nitrile examination gloves with 290mm cuffs providing protection for the hand and forearm.
  • High level protection against many chemical and infectious agents.
  • Protection tested (permeation) with many oncology molecules

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Description
Description

Nitrile Polysem Medical gloves meet the specifications of the two new Medical Device (2017-745 EU) and Personal Protective Equipment (2016-425 EU) regulations
These high level PPE protection gloves are categorized CAT III type B.

They offer good protection against microorganisms and more particularly against viruses.


Finally, these gloves are tested according to the American ASTM D6978 standard for the study of permeation to cytostatic agents and offer a very high level of protection for all teams in contact with cytostatic molecules.


Dispenser box of 100, the Polysem Medical nitrile gloves are available in 4 sizes:   S 67 M 78 L 89 XL910; each size has a specific colour mark.

Technical
information
Technical
information

Indications 
These gloves can be used in most situations where an examination glove is required. Food contact for a limited period: dry, watery, acidic and alcoholic foods (avoid prolonged contact with fatty substances).

Used materials 
Nitrile - Vulcanising agent: Sulphur - Vulcanisation accelerators: ZDEC and ZDBC

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 : NA
  • EU directive/regulation : 2017/745
  • annexe : IV

EPI 

  • european directive(s) - regulation(s) : 2016/425
  • IPE category : III
  • IPE notified body : 2777

sterile 

  • sterile : no

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
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Medical Gloves - Résistance to Chemotherapy Drugs permeation
  • 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 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
  • 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.

economic operator 

  • MANUFACTURER : DIDACTIC / 1800 route des bleuets, Le Mirlibut 76430 Et

Use
Use

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Request the technical sheet

Nitrile Polysem Medical gloves meet the specifications of the two new Medical Device (2017-745 EU) and Personal Protective Equipment (2016-425 EU) regulations
These high level PPE protection gloves are categorized CAT III type B.

They offer good protection against microorganisms and more particularly against viruses.


Finally, these gloves are tested according to the American ASTM D6978 standard for the study of permeation to cytostatic agents and offer a very high level of protection for all teams in contact with cytostatic molecules.


Dispenser box of 100, the Polysem Medical nitrile gloves are available in 4 sizes:   S 67 M 78 L 89 XL910; each size has a specific colour mark.

Indications 
These gloves can be used in most situations where an examination glove is required. Food contact for a limited period: dry, watery, acidic and alcoholic foods (avoid prolonged contact with fatty substances).

Used materials 
Nitrile - Vulcanising agent: Sulphur - Vulcanisation accelerators: ZDEC and ZDBC

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 : NA
  • EU directive/regulation : 2017/745
  • annexe : IV

EPI 

  • european directive(s) - regulation(s) : 2016/425
  • IPE category : III
  • IPE notified body : 2777

sterile 

  • sterile : no

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
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Medical Gloves - Résistance to Chemotherapy Drugs permeation
  • 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 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
  • 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.

economic operator 

  • MANUFACTURER : DIDACTIC / 1800 route des bleuets, Le Mirlibut 76430 Et

Video(s)

Associated products

EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 200 (180 SIZE XL)
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 400MM MEDICAL DEVICE-PPE CAT III - BOX OF 50 UNITS
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 (90 SIZE XL)
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE NO ACCELERATOR 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 UNITS (90 SIZE XL)

Associated products

EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 200 (180 SIZE XL)
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 400MM MEDICAL DEVICE-PPE CAT III - BOX OF 50 UNITS
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 (90 SIZE XL)
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE NO ACCELERATOR 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 UNITS (90 SIZE XL)

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