Standards and Markings
It also introduces strict requirements for PPE suppliers. Now, these requirements are acknowledged internationally helping employers to choose the right PPE, including protective gloves.
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.
EN ISO 21420:2020
PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS
A new standard EN ISO 21420:2020 ‘Protective gloves – General requirements and test methods’ is the new general requirements standard applicable and required for all PPE gloves. EN ISO 21420:2020 has replaced the EN 420:2003+A1:2009 and has adopted by ISO to become a worldwide standard.
EN ISO 21420 attaches great importance to Innocuousness part of testing. Chemical innocuousness helps to ensure that PPE gloves do not have harmful effect to the health or hygiene to the wearer. The main new requirements:
- New limit level of DMFa (dimethylformamide) applicable to all materials containing polyurethane (PU). It must not exceed 1000 mg/kg (1% weight/weight).
- Limited content of polycyclic aromatic hydrocarbons (PAHs) applicable to rubber and plastics in direct contact with the skin, limit: less than 1 mg/kg of each of eight restricted PAH’s.
- Azo colourants – applicable to textiles and all dyed leathers, which releases carcinogenic amines. It must not exceed 30 mg/kg for each of the aromatic amines.
- Nickel release – for all metallic components in prolonged contact with skin, less than 0.5µg/cm2/week.
EN ISO 21420 does not have any minimal glove length, except if specific standard (e.g. welding) has requirements for a minimum length.
Electrostatic Properties marking changed according to EN ISO 21420:2020:
- for ATEX area, the electrostatic properties must be tested in accordance with EN 16350 (test method EN 1149-2), pictogram can be used for gloves meeting requirements of EN 16350.
- for other electrostatic properties, test method EN 1149-1 or EN 1149-3 can be used, but no pictogram.
EN ISO 21420:2020 is adding mandatory requirement for labelling PPE glove with a date of manufacture for better batch traceability and if applicable the date of obsolete with the appropriate pictogram (the hourglass icon).
The certificates issued according EN 420:2003+A1:2009 remain valid until expiry date.
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:
|Performance level||Smallest diameter (mm) of pin that can be picked up with a gloved hand 3 times / 30 seconds.|
Comfort and efficiency. Sizing as per table below:
|EN 420||Equals to||Hand circumference/Length (mm)||Minimum length of the glove (mm)|
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.
GENERAL REQUIREMENTS FOR PROTECTIVE GLOVES
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.
|Circular blade cut resistance|
|Straight blade cut 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.|
|Based on the amount of force required to tear a sample of the glove apart.|
|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.
|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.
|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|
|Straight blade cut resistance (N)|
(EN ISO 13997)
|Impact protection||Pass (level ≤1 9kN)|
Protective Gloves against Mechanical Risks
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.
- 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.
|B||Blade cut resistance||1,2||2,5||5,0||10,0||20,0|
|D ||Puncture resistance||20||60||100||150|
PROTECTIVE GLOVES AGAINST CHEMICALS AND MICRO-ORGANISMS
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.
- PART 3: Resistance to permeation by chemicals.
- (EN 374-3:2016/EN 16523-2015)
- PART 4: Resistance to degradation by chemicals.
- 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.
|BREAKTHROUGH TIME (Min)||> 10||> 30||> 60||> 120||> 240||> 480|
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:
|E||Carbon disulphide||75-15-0||Organic compound containing sulphur|
|H||Tetrahydrofuran||109-99-9||Heterocyclic and ether compound|
|K||40% Sodium hydroxide||1310-73-2||Inorganic base|
|L||96% Sulphuric acid||7664-93-9||Inorganic mineral acid|
|M||65% nitric acid||7697-37-2||Inorganic mineral acid|
|N||99% acetic acid||64-19-7||Organic acid|
|O||25% ammonium hydroxide||1336-21-6||Organic base|
|P||30% hydrogen peroxide||7722-84-1||Peroxide|
|S||40% hydrofluoric acid||7664-39-3||Inorganic mineral acid|
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 374-3:2016/ 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 chemicals must reach at least level 2 performance.
|EN 374-/Type A||EN 374-1/Type B||EN 374-1/Type C|
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|
Protective gloves against chemicals and micro-organisms
This standard specifies gloves capability to act as a barrier against chemicals and/or micro-organisms. It consists of three parts:
- Part 1: Mechanical and physical integrity (according to EN 388:2003)
- Part 2: Resistance to penetration (EN 374-2:2003)
- Part 3: Resistance to permeation by chemicals (EN 374-3:2003)
Part 2: Resistance to penetration (EN 374-2)
Two tests are performed in this part of EN 374:2003:
- Air leak test. Glove is inflated with air pressure and submerged into a tank of water. Leaks are identified by visible bubbles.
- Water leak test. Glove is filled with water and its outer surface is examined for water drops.
Gloves should not leak and should be inspected in compliance with the acceptable quality level (AQL).
|Performance level||Acceptable quality level (AQL)|
The higher the level, the better performance.
A glove is considered as offering protection against bacteria and molds if it achieves at least penetration level 2.
Part 3: Resistance to permeation by chemicals (EN 374-3:2003)
Permeation is a process by which a potentially hazardous chemical moves through a material on a 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 exterior surface of the glove and measuring the time taken until chemical is detected on the inside surface. It gives the indication for how long a glove can be used with a certain chemical.
|Measured Breakthrough time (min)||>10||>30||>60||>120||>240||>480|
Although tests are performed according to the norm, factors such as temperature and stretching have a great influence on how fast the chemical permeates the glove material. Granberg recommends a 25% safety margin.
Full chemical resistance
|List of 12 Standard Defined Chemicals|
|Code Letter||Chemical||CAS number||Class|
|E||Carbon disulfide||75-15-0||Sulphur containing organic compound|
|H||Tetrahydrofurane||109-99-9||Heterocyclic and |
|K||Sodium hydroxide 40%||1310-73-2||Inorganic base|
|L||Sulphuric acid 96%||7664-93-9||Inorganic acid|
Low chemical resistance
- A _ _ L Code letter; refers to the chemical tested.
- 1 _ _ 6 Numeric code; refers to the breakthrough time.
- A _ _ L For gloves with low chemical resistance, reference to tests nad results not required.
- 1 _ _ 6
Protective gloves against thermal risks.
This standard specifies thermal performance for protective gloves against heat and/or fire.
The nature and degree of protection is shown by a pictogram followed by a series of six performance levels, relating to specific protective qualities. Gloves must also achieve at least Performance level 1 for EN 388:2003 standard abrasion and tear.
- aBurning behaviour (x, 0-4)
- bContact heat resistance (x, 0-4)
- cConvective heat resistance (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 - Burning behaviour (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 15 seconds.
The seams of the glove shall not come apart after an ignition time of 15 seconds.
|Performance Level||After Flame Time (s)||After Glow Time (s)|
B - Contact heat resistance (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, glove’s material is exposed to high temperatures (up to 500°C). To gain the relevant performance level, the temperature of the inside of the glove cannot increase more than 10°C within the threshold time (15 seconds).
|Performance Level||Contact Temperature °C||Threshold Time|
C - Convective heat resistance (Performance level 0-4)
Based on the length of time the glove is able to delay the transfer of heat 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 resistance (performance level 0-4)
Based on the length of time the glove is able to delay the transfer of heat when exposed to a radiant heat source.
E - Resistance to small splashes of molten metal (Performance level 0-4)
The number of molten iron (other metals can be tested as required) drops required to heat the glove sample by 40°C, shows the performance level the glove corresponds to.
|Performance Level||Number of droplets|
F - Resistance to large splashes of molten metal (Performance level 0-4)
A quantity of molten iron is poured onto the sample, which has simulant of skin attached to the sample. The weight of molten metal is measured of how much molten metal is required to damage the simulant of skin. The test is failed if metal droplets remain stuck to the specimen or if the specimen is punctured or ignites.
|Performance Level||Molten Iron (g)|
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.
- aConvective cold (x, min. 0, max.)
- bContact cold (x, min. 0, max.)
- 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
Medical Gloves for Single Use
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.
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.
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.
|Surgical Gloves||Examination/Procedure Gloves made of Natural and Synthetic Rubbers||Examination/Procedure Gloves made of Thermoplastics (e.g. Vinyl and TEP material)|
|Force at Break in Newton||≥ 9.0||≥ 6.0||≥ 3.6|
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.
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.
Protective gloves for welders.
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:
|Requirements||Standard||Type A||Type B|
|Abrasion resistance||EN 388||Level 2||Level 1|
|Blade cut resistance||EN 388||Level 1||Level 1|
|Tear resistance||EN 388||Level 2||Level 1|
|Puncture resistance||EN 388||Level 2||Level 1|
|Burning behaviour||EN 407||Level 3||Level 2|
|Contact heat resistance||EN 407||Level 1||Level 1|
|Convective heat resistance||EN 407||Level 2||-|
|Resistance to small splashes of molten metal||EN 407||Level 3||Level 2|
|Dexterity||EN 420||Level 1||Level 4|
*Tungsten inert gas (TIG) welding is an arc welding process that uses a non-consumable tungsten electrode to produce the weld.