Standards and Markings

Categories

In order to comply with a number of requirements in the commercial sector, protective gloves are separated into three categories:

Category I:     For minimal risks.
Category II:    For intermediate risks, e.g. mechanical risks.
Category III:   For irreversible or mortal risks, e.g. injuries from chemicals.

A declaration of conformity is required for all categories. The manufacturer or importer must provide a declaration of conformity upon request.

The new standard EN ISO 21420:2020 is the main standard required for all PPE gloves. EN ISO 21420:2020 has replaced the previous EN 420:2003+A1:2009 and has been adopted by ISO to become a worldwide standard.

It describes the general requirements for all hand protective equipment, such as protective gloves, regarding the following aspects:

• Design and construction
• Innocuousness
• Care and cleaning instructions
• Comfort
• Efficiency
• Marking and information

Glove design and construction

The glove design should allow the wearer to perform normal activities unencumbered while providing the highest degree of protection for the intended application. EN ISO 21420 does not state a minimal glove length. But some specific standards (e.g., for welding) have requirements for a minimum length.

Sizing and measurement

The size of the gloves must be established in relation to the hand sizing system defined in the table below:

Innocuousness of protective gloves

EN ISO 21420 attaches great importance to the innocuousness aspect, which ensures that PPE gloves do not have any harmful effect on the health or hygiene of the wearer. The main requirements are:

• Chromium VI content must be less than 3,0 mg/kg of leather. Applicable for all leather gloves.
• No Nickel release (< 0.5µg/cm2/week). Applicable for all metallic components in prolonged contact with skin.
• pH value must be between 3.5 and 9.5.
• Azo colorants must be less than 30 mg/kg for each of the aromatic amines. Applicable to textiles and all dyed leathers, which releases carcinogenic amines.
• DMFa (dimethylformamide) must not exceed 1000 mg/kg (1% weight/weight). Applicable to all materials containing polyurethane (PU).
• Content of polycyclic aromatic hydrocarbons (PAHs) must be less than 1 mg/kg. Applicable for rubber and plastics in direct contact with the skin.

Cleaning

If cleaning and caring instructions are provided, the relevant performance-related tests must be performed before cleaning and repeated after the maximum recommended number of cleaning cycles. The gloves must be marked according to the lowest performance level results before and after cleaning.

Electrostatic Properties

Regarding ATEX, the electrostatic properties must be tested in accordance with EN 16350 (test method EN 1149-2). The new EN ISO 21420 standard introduced a new pictogram that can be used for gloves that are meeting the requirements of EN 16350 and are tested according to EN 1149-2, for devices intended for use in explosive atmospheres (ATEX zones).                                                                                                                                                                                                                                                                                                                                 

For other electrostatic properties, test method EN 1149-1 or EN 1149-3 can be used and only mentioned in the user’s instruction, but without any pictogram.

Dexterity

The level of dexterity is given by the diameter of the pin that can be picked up by the glove wearer.

Marking and information

Each protective glove must be marked with the following information:

• Manufacturer name
• Glove designation
• Size designation
• Pictograms of applicable standards for the glove, with reference and performance levels
• Manufacturing date   

• Obsolescence date (if applicable) behind the hourglass icon  

If the glove itself can not be marked, the first packing enclosure must contain above listed information.

The user instructions must include the following information:

• Name and address of the manufacturer or representative
• Glove designation
• Available size range
• Intended use with reference to relevant specific standards
• Pictograms of the standards the glove apply to, with reference and performance levels
• Pictograms indicating the hazard category according to PPE regulation (Cat. I, II or III)
• CE mark
• Care & storage instructions
• Instructions and limitations of use
• Name and address of the notified body which certified the product.
• Warnings (if applicable)

General requirements for protective gloves.

All PPE protective gloves must comply with this standard. It covers areas including:

Design and construction

Gloves should provide the highest degree of protection for intended area of use.

Safety and innocuousness

• Glove itself should not cause any harm to user.
• pH value should be between 3.5 and 9.5.
• Chromium VI content should not exceed < 3 mg/kg.
• Latex gloves should be tested on protein content as per EN 455-3.
• Gloves that are designed to reduce the risk of electrostatic discharges, should be tested as per EN 1149 for electrostatic properties.

Dexterity. Performance is graded as per table below:

Comfort and efficiency. Sizing as per table below:

General requirements for instruction of use must include:

• Name and address of the manufacturer or representative;
• Glove designation;
• Available size range;
• CE mark;
• Care & storage instructions;
• Instructions and limitations of use;
• Name and address of notified body that certified the product.

The European Standard EN 388:2016 covers the test requirements for safety gloves that are provided to protect against mechanical risks, which covers abrasion, blade cut, puncture, tearing and impact.

The EN 388:2016 Standard is a revised version of the former EN 388 Standard (EN 388:2003). It has increased the scope of testing required, and the test results thus provide customers with more information, helping them to make the right choice of hand protection for their needs.

ABCDEF		Abrasion resistance
		Circular blade cut resistance
		Tear resistance
		Puncture resistance
		Straight blade cut resistance
		Impact protection

	Abrasion resistance
	Based on the number of cycles needed to abrade through a sample of the glove. Samples are cut from the glove palm and rubbed against sandpaper of a certain quality under a certain constant pressure as defined by the standard. The level of abrasion resistance is measured by the number of cycles reached when a hole appears on the relevant glove sample.

	Circular blade cut resistance
	Based on the number of cycles required to cut through a sample of the glove palm with a circular, counter-rotating blade.

	Tear resistance
	Based on the amount of force required to tear a sample of the glove apart.

	Puncture resistance
	Based on the amount of force required to penetrate the sample with a defined stylus. This is not an indication of the resistance to sharply pointed objects, e.g. hypodermic needle.

Straight blade cut resistance, EN ISO 13997

In the recently revised EN 388 Standard (EN 388:2016), the Circular blade cut resistance test is still in use, and the results from this test are applicable to gloves that do not dull the blade. However, materials that noticeably dull the blade during this test, are now to be tested according to the newly included EN ISO 13997 Straight blade cut resistance test. In these cases, the Circular blade cut resistance test results must be recorded as X (not applicable). EN ISO 13997 determines the force in Newtons (N) required to cut through a material sample.

	Impact Protection
	Gloves that have specific impact resistant properties on the back of the hand can be for tested impact attenuation by measuring the peak transmitted force. In this test, the glove knuckles are impacted by a 2.5 kg flat face striker from a sufficient height, creating an impact energy of 5J. If the sample has achieved a result of Level 1, the letter «P» is added to the results.

	PROTECTION LEVEL		1	2	3	4	5
	Abrasion resistance (No. of cycles)		100	500	2.000	8.000
	Circular blade cut resistance (Index)		1,2	2,5	5,0	10,0	20,0
	Tear resistance (N)		10	25	50	75
	Puncture resistance (N)		20	60	100	150
	PROTECTION LEVEL	A	B	C	D	E	F
	Straight blade cut resistance (N) (EN ISO 13997)	2	5	10	15	22	30
	PROTECTION LEVEL	P
	Impact protection	Pass (level ≤1 9kN)

This standard applies to all protective gloves in respect of physical and mechanical stress caused by abrasion, cut, tearing and puncture.

Protection against mentioned hazards is expressed by a pictogram followed by four numbers (performance levels), each representing test performance against a specific hazard.

abcd

• aAbrasion resistance (x, min. 0, max. 4)
• bBlade cut resistance (x, min. 0, max. 5)
• cTear resistance (x, min. 0, max. 4)
• dPuncture resistance (x, min. 0, max. 4)

Level X means that this test cannot be carried out on this particular glove. The higher the level, the better performance

A – Abrasion resistance
Based on number of cycles needed to abrade through a sample of glove. Samples are cut from glove palm and rubbed against a standard sand paper under a constant standard pressure. Number of cycles is measured when a hole appears on any of the samples.

B – Blade cut resistance
Based on the number of cycles required to cut through the sample from glove palm by circular, counter-rotating blade.

C – Tear resistance
Based on the amount of force required to tear the sample apart.

D – Puncture resistance
Based on the amount of force required to penetrate the sample with a defined stylus. This is not an indication of the resistance to sharply pointed objects, e.g. hypodermic needle.

This standard specifies the requirements against which the capacity of a glove to act as a protective barrier against chemicals and/or micro-organisms is tested.

It consists of five parts:

• PART 1: Mechanical and physical integrity.
  (EN ISO 374-1:2016)
• PART 2: Resistance to penetration.
  (EN 374-2:2014)
• PART 3: Resistance to permeation by chemicals.
  (EN 374-3 suspended, withdrawn/substituted by EN 16523-1:2015)
• PART 4: Resistance to degradation by chemicals.
  (EN 374-4:2013)
• PART 5: Performance requirements for micro-organisms risks.
  (EN ISO 374-5:2016)

Part 2: RESISTANCE TO PENETRATION

Penetration is a physical process whereby a liquid or air penetrates a fabric by passing through pores, seams or pinholes in the fabric.

Two tests are performed in this part of EN 374:2014:

• Air leak test: The glove is inflated with air pressure and submerged into a tank of water. Leaks are identified by visible bubbles.
• Water leak test: The glove is filled with water and its outer surface is examined for water drops.

Part 3: RESISTANCE TO PERMEATION BY CHEMICALS

New permeation test method EN 16523-1:2015 replaces EN 374-3:2003.

Permeation is a process by which a potentially hazardous chemical moves through a material on the molecular level. In the laboratory, permeation is measured by a parameter called breakthrough time.

Breakthrough time is the time a potentially hazardous chemical takes to permeate through the glove material and reach the inside of the glove.

It is determined by applying a potentially hazardous chemical to the exterior surface of the glove and measuring the time it takes before the chemical is detected on the inside surface. It gives an indication of how long a glove can be used with a certain chemical.

Although tests are performed according to the standard, factors such as temperature and stretching have a great influence on how fast the chemical permeates through the glove material. Granberg recommends a 25% safety margin.

EN 374:2016 defines a list of 18 chemicals (6 chemicals are new)

List of test chemicals specified in EN ISO 374-1:2016:

It may only be asserted that gloves protect against Chemical Risks when type A, B or C performance is achieved using permeation test method EN 16523-1:2015.

Type A – Minimum 6 chemicals must reach at least level 2 performance.
Type B – Minimum 3 chemicals must reach at least level 2 performance.
Type C – Minimum 1 chemical must reach at least level 1 performance.

EN 374-1/Type A		EN 374-1/Type B		EN 374-1/Type C
ADJKOT		JKT

Part 4: RESISTANCE TO DEGRADATION BY CHEMICALS

In order to claim that a glove provides protection against a chemical on the list, permeation and degradation tests must be carried out. The results of the degradation test must appear in the User Instructions.

The principle of this test is to assess if a change of a certain nature has occurred in the glove after continuous contact with a chemical. It is de­ter­mined by a puncture resistance test similar to that of EN 388:2016.

Part 5: PERFORMANCE REQUIREMENTS FOR MICRO-ORGANISMS RISKS

Protection against bacteria and fungi can be claimed if penetration (EN374-2:2013) and EN 420 general requirements are met.
It is possible to declare that a glove provides protection against viruses if it meets the requirements of ISO 16604:2004 procedure B.

		EN 374-5		EN 374-5
Protection against bacteria and fungi						Protection against bacteria, fungi and viruses
				VIRUS

Protective gloves and other hand protective equipment against thermal risks.

This standard specifies thermal performance for protective gloves and other hand protective equipment against heat and/or fire.

The European Standard EN 407:2020 is the revised version of the former EN 407:2004 Standard.
The main reason for introducing this new standard is because domestic oven gloves are now included in the regulation for Personal Protective Equipment (PPE). 

This revised version of the standard introduced a second pictogram, which replaces the current pictogram where no flame protection is claimed:

abcdef 

It is used when the performance level for limited flame spread is 0 or x (x=not tested). When this new pictogram is used, the customer is made aware that the glove does not claim any flame protection. The intention behind introducing this new pictogram is for clarity purposes, helping the customer make the right choice in terms of the correct hand protection for their needs with respect to heat and/or fire protection. For flame protecting gloves that have a limited flame spread performance of at least level 1, the previous pictogram is used.

The six performance levels that follow both pictograms remain the same as in the former standard EN 407:2004. The EN 388 abrasion test requirement was removed in the new standard, and only the tear test requirement was kept. This means that gloves marked with EN 407:2020 must achieve at least Performance level 1 for EN 388 standard tear resistance. They also must be in compliance with the European Standard EN 21420:2020.

The 2020 version of the standard contains sizing requirements for minimum length for gloves which claim protection against small and large splashes of molten metal.

To claim performance levels of 3 or 4, for any thermal properties, the limited flame spread test must also be performed, scoring at least a level 3. If this requirement is not met, the maximum level that can be reported for any of the thermal properties shall be level 2.

abcdef 

abcdef

• aLimited flame spread (x, 0-4)
• bContact heat (x, 0-4)
• cConvective heat (x, 0-4)
• dRadiant heat resistance (x, 0-4)
• eResistance to small splashes of molten metal (x, 0-4)
• fResistance to large splashes of molten metal (x, 0-4)

Level X means that this test cannot be carried out on this particular glove. The higher the level, the better performance.

a – Limited flame spread (Performance level 0-4)
Based on the length of time the material continues to burn and glow after the source of ignition is removed. The flame is held against the material for 10 seconds.

b – Contact heat (Performance level 0-4)
Based on the temperature range at which the user will feel no pain for at least 15 seconds. During the testing, the glove’s material is exposed to high temperatures (up to 500°C). To gain the relevant performance level, the temperature inside the glove cannot increase more than 10°C within the threshold time (15 seconds).

c – Convective heat (Performance level 0-4)
Based on the length of time the glove is able to delay the heat transfer from a flame.
Samples are subjected to the incident heat from a flame, and the amount of time is measured to increase of the glove’s inside material by 24°C.

d – Radiant heat (performance level 0-4)
Based on the length of time the glove can delay the transfer of heat when exposed to a radiant heat source. 

e – Small splashes of molten metal (Performance level 0-4)
The number of molten iron drops (other metals can be tested as required) required to heat the glove sample by 40°C, shows the performance level the glove corresponds to. 

f – Large quantities of molten metal (Performance level 0-4)
A quantity of molten iron is poured onto the sample, which has a piece of simulated skin attached to the sample. The weight of molten metal is measured, determining how much molten metal is required to damage the simulated skin. The test has failed if metal droplets remain stuck to the specimen or if the specimen is punctured or ignites.

Gloves giving protection from cold (down to -50°C).

Protection against cold is expressed by a pictogram followed by a series of 3 performance levels, relating to specific protective qualities.

abc

• aConvective cold (x, min. 0, max. 4)
• bContact cold (x, min. 0, max. 4)
• cPenetration by water (x, 0/1 – after 30 min)

Level X means that this test cannot be carried out on this particular glove. The higher the level, the better performance.

A – Resistance to convective cold (Performance level 0 – 4)

Based on the thermal insulation properties of the glove. The power required to maintain a constant temperature on a heated hand model in a climatic room is measured. 

B – Resistance to contact cold (Performance level 0 – 4)

Based on the thermal resistance of the glove material when exposed to contact with a cold object.

C – Penetration by water (0 or 1)

0 = water penetrates after 30 minutes of exposure
1 = water does not penetrate after 30 minutes of exposure

This standard specifies requirements and tests for gloves for medical purpose. Requirements are detailed in the Medical Device Directive 93/42/EEC.
This includes tests to assess the freedom from holes, the dimensions of the gloves and the mechanical strength of its materials, both before and after an ageing process.

Part 1
EN 455-1 covers requirements and testing of gloves for freedom from holes. For this test the standard uses a water leak test to which randomly sampled gloves are subjected. A statistical sample taken from a batch must achieve an acceptable quality level (AQL) of 1.5 or better in order to be used as examination, procedure or surgical gloves.
AQL 1.5 is equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing water, and therefore micro-organisms, through the material.

Part 2
EN 455-2 describes the testing requirements for determination of physical properties, including tensile strength, before and after accelerated ageing, of medical gloves.  Gloves are treated differently depending on the use they are intended for and the material they are manufactured from.

Part 3
EN 455-3 covers requirements and testing for biological evaluation. It specifies methods for protein testing (extractable latex proteins have an important role in latex allergy), powder levels, and endotoxin levels.

Part 4
EN 455-4 covers requirements and testing for shelf life determination. It specifies real-time and accelerated shelf life studies, to enable manufacturers to prove that their product will withstand up to 3 years (usually) without losing their properties as well as complying with the requirements of the EN 455.

This standard applies to protective gloves for use in manual metal welding, cutting and allied processes.  It includes reference to EN 420, EN 388 and EN 407 requirements.

Compliance to EN 420, except for lengths:

Size 6: 300mm
Size 7: 310mm
Size 8: 320mm
Size 9: 330mm
Size 10: 340mm
Size 11: 350mm

Type A: lower dexterity and higher performance for physical characteristics. This type is recommended for all welding operations where higher protection would be needed, except TIG* welding

Type B: higher dexterity and lower physical performance. This type is recommended for TIG welding.

Minimum performance required:

*Tungsten inert gas (TIG) welding is an arc welding process that uses a non-consumable tungsten electrode to produce the weld.

The Regulation (EU) 2017/745 for medical devices entered into force in May 2017 to replace the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). The intention for introducing this new regulation is to improve the quality, safety, reliability, and transparency of medical devices that are placed on the European market.

The regulation defined rules and obligations for manufacturers and other economic operators for their quality and safety management. The regulation improves patient safety by setting strict procedures for conformity to make sure that no non-compliant and unsafe medical device is sold in the EU.

It also introduces a new system to ensure traceability and transparency of the medical devices throughout the supply chain. Medical devices and manufacturers, importers, etc. are registered with a unique device identifier (UDI). This system allows faster investigations when problems occur with a product. Information about all medical devices on the EU market will be available for patients, consumers, and the public on a centralized database (Eudamed).

The UKCA marking is equal to the CE mark and applicable only for products that are placed on the Great Britain market (England, Wales and Scotland).

The EAC mark is applicable for products that are placed on the Eurasian market (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan). It shows that the product is in compliance with the norms of the Eurasian Customs Union.