Standards and Markings


European standards have been developed to unify national provisions relating to PPE across Member States. Council Directive 89/391/EEC sets  broad guidelines for health and safety at workplace and places a duty for employer “to make appropriate personal protective equipment available to their staff”.  It also introduces strict requirements for PPE suppliers. Now these requirements are acknowledged internationally helping employers to choose the right PPE, including protective gloves.

Standards

General Requirements

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.

EN 420:2003

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.
1 11.0
2 9.5
3 8.0
4 6.5
5 5.0

Comfort and efficiency. Sizing as per table below:

EN 420 EQUALS TO HAND CIRCUMFERENCE/LENGTH (MM) MINIMUM LENGTH OF THE GLOVE (MM)
6 XS 152/160 220
7 S 178/171 230
8 M 203/182 240
9 L 229/192 250
10 XL 254/204 260
11 XXL 279/215 270

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.
EN 388:2003

EN 388:2003

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.

EN 388
 abcd
  • A— Abrasion resistance (x, min. 0, max. 4)
  • B— Blade cut resistance (x, min. 0, max. 5)
  • C— Tear resistance (x, min. 0, max. 4)
  • D— Puncture 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.

– 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.

 TEST PERFORMANCE LEVEL
1 2 3 4 5
A
Abrasion resistance 100 500 2.000 8.000
Blade cut resistance 1,2 2,5 5,0 10,0 20,0
Tear resistance 10 25 50 75

Puncture resistance 20 60 100 150
EN 374:2003

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)

EN374-2
EN 388Penetration is a physical process whereby a liquid or air penetrates a fabric by passing through pores, seams or pinholes in the fabric
    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)
3 <0,65
2 <1,5
1 <4,0

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.

PERFORMANCE LEVEL 1 2 3 4 5 6
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.

en-374..-02
LIST OF 12 STANDARD DEFINED CHEMICALS
Code Letter Chemical CAS number Class
A Methanol 67-56-1 Primary alcohol
B Acetone 67-64-1 Ketone
C Acetonitrile 75-05-8 Nitrile compound
D Dichloromethane 75-09-2 Chlorinated paraffin
E Carbon disulfide 75-15-0 Sulphur containing organic compound
F Toluene 108-88-3 Aromatic hydrocarbon
G Dietylamine 109-89-7 Amine
H Tetrahydrofurane 109-99-9 Heterocyclic and
ether compound
I Ethyl acetate 141-78-6 Ester
J n-Heptane 142-82-5 Saturated hydrocarbon
K Sodium hydroxide 40% 1310-73-2 Inorganic base
L Sulphuric acid 96% 7664-93-9 Inorganic acid
en-374..-01
EN 407:2004

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.

EN 407
abcdef
  • A— Burning behaviour (x, 0-4)
  • B— Contact heat resistance (x, 0-4)
  • C— Convective heat resistance (x, 0-4)
  • D— Radiant heat resistance (x, 0-4)
  • E— Resistance to small splashes of molten metal(x, 0-4)
  • F— Resistance 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)
1 20 No requirement
2 10 120
3 3 25
4 2 5

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
1 100 15
2 250 15
3 350 15
4 500 15

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
1 10
2 15
3 25
4 35

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)
1 30
2 60
3 120
4 200
EN 511:2006

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.

EN 5111
   abc
  • A— Convective cold (x, min. 0, max.)
  • B— Contact cold (x, min. 0, max.)
  • C— Penetration 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

EN 455

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.

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.

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

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.

EN 12477:2001

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.

Pictograms for the Various Relevant Standards

Pictograms for the Various Relevant Standards

pictogram
NederlandsEnglishFrançaisDeutschItalianoPortuguêsРусскийEspañol