LATEX ANATOMICAL PROCEDURE GLOVES POLYSEM MEDICAL SINGLE USE STERILE SLEEVE PPE CAT III BOX OF 50 PAIRS

  • The Polysem Medical sterile latex procedure gloves meet the technical specifications for a latex surgical glove.
  • They are available in 1/2 sizes in order to adapt to the size of the operators' hands.
  • These gloves are rated as both a Class IIa medical device and Category III type B Personal Protective Equipment.

Description

Polysem Medical intervention gloves are indicated when the use of a sterile anatomical glove is required.


They can in particular be used in emergency units, in care units (urinary catheterization, repair of dressings, etc.) and also for small surgery of very short duration.
The packaging in a dispenser box makes it very easy to take the pocket (folded format) two-sided paper-PE

Technical
information

Indications 
Non-invasive procedures requiring a conformable sterile glove; Surgical procedures of short duration

Used materials 
Latex and natural rubber - Vulcanising agent: Sulphur, Zinc oxide - Vulcanisation accelerators: ZDEC and ZDBC

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 : IIa
  • MD notified body : 1639
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

EPI 

  • european directive(s) - regulation(s) : 2016/425
  • IPE category : III
  • IPE notified body : 2777

sterile 

  • sterile : yes
  • sterilization method : gamma ray

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
  • Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • 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 mechanical risks
  • 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

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
CASE 0 3661809228605
UNIT 1 3661809028601
BOX 50 25 x 14 x 13 1.560 3661809128608

Polysem Medical intervention gloves are indicated when the use of a sterile anatomical glove is required.


They can in particular be used in emergency units, in care units (urinary catheterization, repair of dressings, etc.) and also for small surgery of very short duration.
The packaging in a dispenser box makes it very easy to take the pocket (folded format) two-sided paper-PE

Indications 
Non-invasive procedures requiring a conformable sterile glove; Surgical procedures of short duration

Used materials 
Latex and natural rubber - Vulcanising agent: Sulphur, Zinc oxide - Vulcanisation accelerators: ZDEC and ZDBC

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 : IIa
  • MD notified body : 1639
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

EPI 

  • european directive(s) - regulation(s) : 2016/425
  • IPE category : III
  • IPE notified body : 2777

sterile 

  • sterile : yes
  • sterilization method : gamma ray

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
  • Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • 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 mechanical risks
  • 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 heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
CASE 0 3661809228605
UNIT 1 3661809028601
BOX 50 25 x 14 x 13 1.560 3661809128608

Request for technical documentation

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