RULES

SANTEX PRODUCT STANDARDS

EN ISO 21240 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).

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:

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

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

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

· 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

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.
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 1591/2009, regulating medical devices
• .Royal Decree 192/2023 which regulates health products.
  

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

	EC marking in compliance with European regulations concerning medical devices and personal protective equipment.
	Products that meet the regulatory requirements for food contact.
	Single use only.
	Some elements of the product or packaging are recyclable.
	Keep in a dry place.
	Caution, contains latex.
	Keep protected from sunlight or fluorescent light.
	Instructions for use.
	Glove without dust.

 

	Medical device
	Número de lote
	Manufacturing date
	Date of Expiry
	Non-sterile
	Temperature limit