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

Reference : 1144
size 

  • Non-sterile nitrile examination glove with no sulfides or gas pedals (limits type IV allergies) for hand and forearm protection.
  • Ultra-comfortable glove with long cuff.
  • For professional use.
  • 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.
  • Robustness for greater durability.

Palm thickness: 0.10mm.

Finger thickness: 0.11mm.

Glove length > 290mm

Color: blue.

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Description
Description

Kolmi nitrile gloves are designed and certified under an ISO 13485 ISO 9001 certified quality system. They 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. En 421 for protection against radioactive particles.



These gloves have been tested in accordance with ASTM D6978-05 for the study of permeation by chemotherapy drugs (Busulfan, Carmustine, Cyclophosphamide, Doxorubicin, Etoposide, Fluorouracil, Irinotecan, Paclitaxel, Thiotepa, Vidaza) and Fentanyl.

In compensating 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

Technical
information
Technical
information

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).

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 : 0075

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
  • 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.

Logistics
information
Logistics
information

Transport conditions 

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

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1
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Request the technical sheet

Kolmi nitrile gloves are designed and certified under an ISO 13485 ISO 9001 certified quality system. They 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. En 421 for protection against radioactive particles.



These gloves have been tested in accordance with ASTM D6978-05 for the study of permeation by chemotherapy drugs (Busulfan, Carmustine, Cyclophosphamide, Doxorubicin, Etoposide, Fluorouracil, Irinotecan, Paclitaxel, Thiotepa, Vidaza) and Fentanyl.

In compensating 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).

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 : 0075

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
  • 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.

Transport conditions 

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

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1

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

Request for technical documentation

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