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EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 (90 SIZE XL)

Reference : GN100
size 

  • Non-sterile nitrile examination gloves with 240 mm 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.

- Cuff length: 240mm
- Thickness 0,12 mm
- Colour: lavender blue


Dispenser box of 100 (90 in size XL), the Polysem Médical nitrile gloves are available in 5 sizes: XS 56 S 67 M 78 L89 XL910; each size has a specific colour mark.


EN 455-3 Biological evaluation tested according EN ISO 21171-2006 standard.

Technical
information
Technical
information

Indications 
These gloves can be used in most situations where an examination glove is required. Food contact (19-35/2004 UE Regulation) for a limited period: dry, watery, acidic and alcoholic foods (avoid prolonged contact with fatty substances).

Used materials 
May contain : Base material: Nitrile-butadiene rubber (NBR) PH adjuster: Potassium hydroxide Vulcanising agent: Sulphur Vulcanisation accelerators: Zinc diethyldithiocarbamate, Zinc dibutyldithiocarbamate, Zinc 2-mercaptobenzothiazole Cross-linking system: water-based cross-linker Cross-linking additive: zinc oxide Pigments : Titanium Dioxide, Blue Pigment, Violet Pigment Internal coating: Polyacrylate-based Exterior: Calcium stearate Antioxidant: Wingstay-L

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 B
  • 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
  • Protective gloves — General requirements and test methods
  • 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 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 / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

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.

- Cuff length: 240mm
- Thickness 0,12 mm
- Colour: lavender blue


Dispenser box of 100 (90 in size XL), the Polysem Médical nitrile gloves are available in 5 sizes: XS 56 S 67 M 78 L89 XL910; each size has a specific colour mark.


EN 455-3 Biological evaluation tested according EN ISO 21171-2006 standard.

Indications 
These gloves can be used in most situations where an examination glove is required. Food contact (19-35/2004 UE Regulation) for a limited period: dry, watery, acidic and alcoholic foods (avoid prolonged contact with fatty substances).

Used materials 
May contain : Base material: Nitrile-butadiene rubber (NBR) PH adjuster: Potassium hydroxide Vulcanising agent: Sulphur Vulcanisation accelerators: Zinc diethyldithiocarbamate, Zinc dibutyldithiocarbamate, Zinc 2-mercaptobenzothiazole Cross-linking system: water-based cross-linker Cross-linking additive: zinc oxide Pigments : Titanium Dioxide, Blue Pigment, Violet Pigment Internal coating: Polyacrylate-based Exterior: Calcium stearate Antioxidant: Wingstay-L

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 B
  • 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
  • Protective gloves — General requirements and test methods
  • 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 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 / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

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 290MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 UNITS
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 400MM MEDICAL DEVICE-PPE CAT III - BOX OF 50 UNITS
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 290MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 UNITS
EXAMINATION GLOVE NITRILE NON STERILE POWDER FREE 400MM MEDICAL DEVICE-PPE CAT III - BOX OF 50 UNITS
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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