Background

RULES

SANTEX PRODUCT STANDARDS

EN420:2003 sets out the general requirements for all protective gloves (design and manufacture, safety, comfort and efficiency, identification and information).

EN374 This group of standards sets out the requirements for gloves intended to protect the user against chemicals and/or micro-organisms. This standard does not establish mechanical protection requirements. It establishes the conditions for evaluating the following parameters:

  • Determination of resistance to penetration (EN 374-2:2014).
EN 374 A glove must not present leaks subjected to an air/water test and must be able to withstand without detectable leaks for 30 minutes in order to be assigned the pictogram.
  • Permeation by liquid chemicals under conditions of continuous contact..

This is carried out in accordance with EN 16523-1, with the associated protection classes:

Permeation time measured Protection index
▷ 10 minutes Class 1
▷ 30 minutes Class 2
▷ 60 minutes Class 3
▷ 120 minutes Class 4
▷ 240 minutes Class 5
▷ 480 minutes Class 6

In turn. according to this set of rules the gloves are divided into:

EN 374 ▷ Type A: those that have been tested to the permeation of 6 chemical products of the table and have at least level 2.
EN 374 ▷ Type B: those that have been tested to the permeation of 3 chemicals from the table and have at least a level 2.
EN 374 ▷ Type C: those that have been tested at the permeation of 1 chemical from the table and have at least a level of 1.

Identifying with letters the chemicals with which the permeation has been tested.

  • Determination of resistance to chemical degradation EN374-4:2013.

It assumes a categorization according to the deterioration of some of the properties of the glove due to contact with a chemical product. E.g.: discoloration, hardening, softening, etc.

  • Determination of the level of protection against microorganisms..
 EN 374 Protective gloves against micro-organisms offer protection against bacteria and fungi when they comply with EN 374-2:2014 (air leakage and water leakage).
EN 374
VIRUS
Gloves that also offer protection against viruses must comply be tested according with ISO 16604.

EN388:2016 sets the criteria for gloves protecting against physical and mechanical actions (abrasion, knife cutting, perforation, tearing and impact):

 EN 388 · Abrasion resistance: levels 0 to 4.
· Resistance to cutting by blade: levels 0 to 5.
· Resistance to tearing: levels 0 to 4.
· Puncture resistance: levels 0 to 4.
· Resistance to cutting by sharp objects: levels A to F + X.
· Protection against impact, according to EN 13594:2015

EN455 these standards set the requirements for medical gloves. Specifically:

EN455-1: Requirements and tests to determine the absence of holes.
EN455-2: Requirements and tests for the determination of physical properties.
EN455-3: Requirements and tests for biological evaluation. (Standard under revision)
EN455-4: Requirements and tests for the determination of the useful life.

EN1186 these standards establish the requirements for plastic materials and articles in contact with foodstuffs.

REGULATION

Spanish:

  • ·  Royal Decree 1407/1992, regulating the conditions for the marketing and free movement of personal protective equipment within the Community.
  • ·  Royal Decree 1591/2009, regulating medical devices.
  • ·  Royal Decree 866/2008, approving the list of substances permitted for the manufacture of plastic materials and objects intended to come into contact with food and regulating certain test conditions.

European:

  • ·  Regulation (EU) 2016/425 on personal protective equipment.
  • ·  Regulation (EU) 2017/745 on medical devices.
  • ·  Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance.
  • ·  Regulation (EU) 2016/1416 on plastic materials and articles intended to come into contact with food.
  • ·  Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

PICTOGRAMS

 CE EC marking in compliance with European regulations concerning medical devices and personal protective equipment.
 imagen Products that meet the regulatory requirements for food contact.
 Un solo uso Single use only.
 Reciclables Some elements of the product or packaging are recyclable.
 Lugar Seco Keep in a dry place.
 Látex Caution, contains latex.
 lugar con luz Keep protected from sunlight or fluorescent light.
 Instrucciones Instructions for use.
 POWDER FREE Glove without dust.