KOLMI COVERFEEL TOUCH NITRILE GLOVE BLUE POWDER-FREE MEDICAL DEVICE - EPI CAT III TYPE B

  • Non-sterile nitrile examination glove with no sulfides or gas pedals (limits type IV allergies) for hand and forearm protection.
  • Ultra-comfortable glove.
  • Professional-use glove.
  • Faster donning thanks to internal polymer coating.
  • High-level protection against many chemical and infectious agents.
  • Tested protection (permeation) with many oncology molecules.
  • Waterproof and airtight glove.
  • Non-slip texture for excellent grip and handling.
  • High elasticity and dexterity.

Palm thickness: 0.07mm.

Finger thickness: 0.08mm.

Color: blue.

Description

Kolmi nitrile gloves meet the specifications of both Regulations: medical devices (2017-745 EU) and personal protective equipment (2016-425 EU).
These high-level PPE gloves comply with CAT III type B.

They offer good protection against tested chemicals (type B) and microorganisms, including viruses.

These gloves have been tested in accordance with ASTM D6978-05 for permeation studies on chemotherapeutic drugs (Busulfan, Carotene, etc.).(Busulfan, Carmustine, Cyclophosphamide, Doxorubicin, Etoposide, Fluorouracil, Irinotecan, Paclitaxel, Thiotepa, Vidaza) and Fentanyl.

Available in boxes of 100 (90 for sizes XL and XXL), these gloves come in 6 sizes:

- T6, XS

- T7, S

- T8, M

- T9, L

- T10, XL,

- T11, XXL

Informations
techniques

Indications 
These gloves can be used in most situations where an examination glove is required. For use on healthy skin only. Single use, do not reuse. Food contact (in compliance with Regulation 1935/2004 EC) for all types of foodstuffs (short-term use).

Étiquetage 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

dispositif médical 

  • 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 : 0075

stérile 

  • stérile : no

conformité 

  • 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
  • Protective gloves against chemicals and micro-organisms - Part 2 : determination of resistance to penetration
  • 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 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.

Informations
logistiques

Conditions de transport 

Protected from light, humidity and at a temperature between 5 and 40 ° C

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1

Kolmi nitrile gloves meet the specifications of both Regulations: medical devices (2017-745 EU) and personal protective equipment (2016-425 EU).
These high-level PPE gloves comply with CAT III type B.

They offer good protection against tested chemicals (type B) and microorganisms, including viruses.

These gloves have been tested in accordance with ASTM D6978-05 for permeation studies on chemotherapeutic drugs (Busulfan, Carotene, etc.).(Busulfan, Carmustine, Cyclophosphamide, Doxorubicin, Etoposide, Fluorouracil, Irinotecan, Paclitaxel, Thiotepa, Vidaza) and Fentanyl.

Available in boxes of 100 (90 for sizes XL and XXL), these gloves come in 6 sizes:

- T6, XS

- T7, S

- T8, M

- T9, L

- T10, XL,

- T11, XXL

Indications 
These gloves can be used in most situations where an examination glove is required. For use on healthy skin only. Single use, do not reuse. Food contact (in compliance with Regulation 1935/2004 EC) for all types of foodstuffs (short-term use).

Étiquetage 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

dispositif médical 

  • 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 : 0075

stérile 

  • stérile : no

conformité 

  • 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
  • Protective gloves against chemicals and micro-organisms - Part 2 : determination of resistance to penetration
  • 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 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.

Conditions de transport 

Protected from light, humidity and at a temperature between 5 and 40 ° C

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1

Produits associés

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 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 (90 SIZE XL)

Produits associés

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 240MM MEDICAL DEVICE-PPE CAT III TYPE B- BOX OF 100 (90 SIZE XL)

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