{"id":26067,"date":"2024-06-21T11:09:30","date_gmt":"2024-06-21T11:09:30","guid":{"rendered":"https:\/\/santex.es\/santex-product-standards\/"},"modified":"2025-06-19T09:22:39","modified_gmt":"2025-06-19T09:22:39","slug":"regulations","status":"publish","type":"page","link":"https:\/\/www.santex.es\/en\/regulations\/","title":{"rendered":"SANTEX PRODUCT STANDARDS"},"content":{"rendered":"\t\t
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SANTEX PRODUCT STANDARDS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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: <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Determination of resistance to penetration (EN 374-2:2014).<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tA 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.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Permeation by liquid chemicals under conditions of continuous contact..<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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This is carried out in accordance with EN 16523-1, with the associated protection classes:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Permeation time measured<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Protection index<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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10 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 1<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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30 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 2<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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60 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 3<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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120 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 4<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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240 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 5<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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480 minutes<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Class 6<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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In turn according to this set of rules the gloves are divided into:<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\tType A: those that have been tested to the permeation of 6 chemical products of the table and have at least level 2.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t Type B: those that have been tested to the permeation of 3 chemicals from the table and have at least a level 2.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t Type C: those that have been tested at the permeation of 1 chemical from the table and have at least a level of 1.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Identifying with letters the chemicals with which the permeation has been tested.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Determination of resistance to chemical degradation EN374-4:2013.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Determination of the level of protection against microorganisms..<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tProtective gloves against micro-organisms offer protection against bacteria and fungi when they comply with EN 374-2:2014 (air leakage and water leakage).\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tGloves that also offer protection against viruses must comply be tested according with ISO 16604.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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EN388 sets the criteria for gloves protecting against physical and mechanical actions (abrasion, knife cutting, perforation, tearing and impact):<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\u00b7 Abrasion resistance: levels 0 to 4.
\u00b7 Blade cut resistance: levels 0 to 5.
\u00b7 Tear resistance: levels 0 to 4.
\u00b7 Puncture resistance: levels 0 to 4.
\u00b7 Cut resistance from sharp objects: levels A to F.
\u00b7 Impact protection, according to EN 13594 standard.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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REGULATION
<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spanish:<\/strong>
\u00b7 Royal Decree 1591\/2009, regulating medical devices<\/p>

Royal Decree 192\/2023 which regulates health products.<\/p>

European:<\/strong>
\u00b7 Regulation (EU) 2016\/425 on personal protective equipment.
\u00b7 Regulation (EU) 2017\/745 on medical devices.
\u00b7 Regulation (EU) No 10\/2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance.
\u00b7 Regulation (EU) 2016\/1416 on plastic materials and articles intended to come into contact with food.
\u00b7 Regulation (EC) No 1935\/2004 on materials and articles intended to come into contact with food.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Pictograms<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tEC marking in compliance with European regulations concerning medical devices and personal protective equipment.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\tProducts that meet the regulatory requirements for food contact.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\tSingle use only.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\tSome elements of the product or packaging are recyclable.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tKeep in a dry place.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tCaution, contains latex.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tKeep protected from sunlight or fluorescent light.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tInstructions for use.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t<\/span><\/span>Glove without dust.<\/span>\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tMedical device\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tN\u00famero de lote\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tManufacturing date\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tDate of Expiry\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tNon-sterile\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\n\t\t\t\t\t\t
\n\t\t\t\t\n\t\t\t\t<\/rect><\/g><\/use><\/pattern><\/image><\/defs><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t<\/span><\/span>Temperature limit<\/span>
\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

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 […]<\/p>\n","protected":false},"author":7,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-26067","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nRegulations: EN 374, EN 455, etc. - Santex Internacional<\/title>\n<meta name=\"description\" content=\"In Santex we want to keep customers informed, so we have developed this page to inform about the regulations of our products.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.santex.es\/en\/regulations\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulations: EN 374, EN 455, etc. - Santex Internacional\" \/>\n<meta property=\"og:description\" content=\"In Santex we want to keep customers informed, so we have developed this page to inform about the regulations of our products.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.santex.es\/en\/regulations\/\" \/>\n<meta property=\"og:site_name\" content=\"Santex\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-19T09:22:39+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.santex.es\\\/en\\\/regulations\\\/\",\"url\":\"https:\\\/\\\/www.santex.es\\\/en\\\/regulations\\\/\",\"name\":\"Regulations: EN 374, EN 455, etc. - 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