LATEX HIGH PROTECT EXAMINATION GLOVE 240MM NON-STERILE POWDER-FREE MEDICAL DEVICE - EPI CAT III - BOX OF 100

Polysem Medical's non-sterile latex examination gloves meet the technical specifications of a latex examination glove.
These gloves have both Class I Medical Device and Category III Type B Personal Protective Equipment status.
Low protein content

Polysem Medical examination gloves are used in particular in emergencies, in care units (urinary catheterization, dressing repairs....) and also for minor surgical procedures of very short duration.

PPE cat III and type B, providing very high protection against micro-organisms and chemical substances
Cuff size: 240 mm

Color: creamy white

Indications
All short-term procedures requiring an examination glove.

Used materials
Latex and natural rubber - Vulcanising agent: Sulphur - Vulcanisation accelerators: ZDEC and ZMBT

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
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-

Transport conditions

Protected from light, humidity and at a temperature between 10 and 30 ° C

Polysem Medical examination gloves are used in particular in emergencies, in care units (urinary catheterization, dressing repairs....) and also for minor surgical procedures of very short duration.

PPE cat III and type B, providing very high protection against micro-organisms and chemical substances
Cuff size: 240 mm

Color: creamy white

Indications
All short-term procedures requiring an examination glove.

Used materials
Latex and natural rubber - Vulcanising agent: Sulphur - Vulcanisation accelerators: ZDEC and ZMBT

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
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-

Transport conditions

Protected from light, humidity and at a temperature between 10 and 30 ° C

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

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LATEX HIGH PROTECT EXAMINATION GLOVE 240MM NON-STERILE POWDER-FREE MEDICAL DEVICE - EPI CAT III - BOX OF 100

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