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

  • Non-sterile, powder free, flexible and hard-wearing vinyl examination gloves.
  • They provide healthcare professionals with a high level of protection against many infectious agents, particularly viruses.
  • They are latex-free and have a very good level of skin tolerance.

Description

Intended for simple, everyday healthcare requiring a bacteriological barrier, Polysem Medical vinyl examination gloves provide optimal protection.

Made of polyvinyl chloride, they do not contain natural latex, significantly reducing the risk of allergies.

Polysem Medical vinyl 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.


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

Cuff length: 240mm

Colour: Translucent

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 
May contain : Base material: Polyvinyl chloride Plasticizer : Di-2-ethylhexyl terephthalate (DOTP), Diisononyl phthalate DINP, TXIB Stabiliser: Calcium-Zinc, Epoxidised soya oil Release agent: PU Vulcanisation activator: Zinc octoate/Calcium oleate Water-based polyurethane coating agent Dearomatised hydrocarbons

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 - 2797

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
  • 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-

Intended for simple, everyday healthcare requiring a bacteriological barrier, Polysem Medical vinyl examination gloves provide optimal protection.

Made of polyvinyl chloride, they do not contain natural latex, significantly reducing the risk of allergies.

Polysem Medical vinyl 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.


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

Cuff length: 240mm

Colour: Translucent

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 
May contain : Base material: Polyvinyl chloride Plasticizer : Di-2-ethylhexyl terephthalate (DOTP), Diisononyl phthalate DINP, TXIB Stabiliser: Calcium-Zinc, Epoxidised soya oil Release agent: PU Vulcanisation activator: Zinc octoate/Calcium oleate Water-based polyurethane coating agent Dearomatised hydrocarbons

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 - 2797

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
  • 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 PVC NON STERILE POWDER FREE 290MM MEDICAL DEVICE-PPE CAT III - BOX OF 100 UNITS
EXAMINATION GLOVE VINYL SOFT ELASTIC 240MM NON STERILE POWDER FREE MEDICAL DEVICE-PPE CAT III-BOX OF 100
EXAMINATION GLOVE PVC NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III - BOX OF 200 (180 SIZE XL)
LONG CUFF STRETCH VINYL GLOVE NON-STERILE POWDER FREE AMBIDEXTROUS

Associated products

EXAMINATION GLOVE PVC NON STERILE POWDER FREE 290MM MEDICAL DEVICE-PPE CAT III - BOX OF 100 UNITS
EXAMINATION GLOVE VINYL SOFT ELASTIC 240MM NON STERILE POWDER FREE MEDICAL DEVICE-PPE CAT III-BOX OF 100
EXAMINATION GLOVE PVC NON STERILE POWDER FREE 240MM MEDICAL DEVICE-PPE CAT III - BOX OF 200 (180 SIZE XL)
LONG CUFF STRETCH VINYL GLOVE NON-STERILE POWDER FREE AMBIDEXTROUS

Request for technical documentation

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