Protective gloves

Product definition

Protective gloves are gloves which offer the wearer hand and arm protection against one or more risks that they may encounter. As such products are designed to provide protection to the user, they are regulated under the Regulation (EU) 2016/425 on personal protective equipment.

PPE are classified in three categories depending on the risk against which they protect. Protective gloves can be found in any of the three categories:

• Category I: gloves providing protection against superficial mechanical injury, against cleaning materials of weak action, etc. E.g. gloves for gardening, for dishwashing, etc.
• Category II: gloves providing general mechanical or temperature protection, etc. E.g. gloves for motorcyclists providing mechanical protection, heat resistant gloves (<100C), dry gloves for divers, etc.
• Category III: gloves providing protection against hazardous substances, against electric shock, etc. E.g. chemical resistant gloves, gloves for electricians, etc.

Gloves that have a medical purpose in the patient environment are also medical devices and fall also under the scope of the Medical Devices Regulation (EU) 2017/745. Their classification depends of the associated risk: examination gloves are class I devices, while surgical gloves are in class IIa as surgically invasive devices intended for transient use.

NB: For this product category, certificates are only recommended as well as involving a third party laboratory in the conformity assessment.

Common risks of protective gloves

This is a list of examples of common risks. However, the manufacturer has to carry out an assessment of the protective gloves that covers all relevant risks that may be associated with the product and actions taken to mitigate these risks where possible. The categorization of the gloves in one of the three PPE categories will depend on the result of this risk assessment. The appendix of the PPE Regulation Guidelines includes a guide for the categorization of PPE, including some examples for gloves. A general definition of risk and its relationship to hazards can be found in the factsheet on Risk management.

The most obvious risk with protective gloves is that it does not offer the level of protection claimed or expected by the user, who may be injured because of reliance on the stated or expected level of protection. Some of these are listed below:

• Burns caused by insufficient heat insulation (for example oven gloves)
• Abrasion caused by ineffective materials which can range in severity between minor (e.g. for gardening gloves) to more serious (e.g. for those for use on motorcycles or with chainsaws).
• Other health risks such as for gloves which are designed to protect against biological agents or hazardous chemicals.
• Other temperature related injuries where gloves are designed to protect against extreme cold but fail to do so.

In addition, some products may present a risk to the wearer just by being worn, and these are independent of the protective mechanism. The most common risks are:

1. Inappropriate constituent materials – dangerous chemicals can cause short- and long-term adverse health effects if they exceed allowed limits, or the presence of flammable materials can present a risk in case of high temperature environments.
2. Lack of adaptation to the user morphology – for example gloves that do not properly fit the wearer can lead to reduced dexterity for the user in what might be a hazardous environment, increasing the risk of injury.
3. Other design risks – for example gloves with heating elements can present an electrical risk to the wearer.

Examples of dangerous products

Specific examples of measures taken against dangerous protective gloves offered for sale in the European Union are available on the Safety Gate website. Type ‘gloves’ into the free text search box (but without the quotation marks). A better understanding of mistakes made in the safety assessment of gloves, or their manufacture can help avoid their repetition.

Main applicable legislation

These products are regulated mainly by the Personal Protective Equipment Regulation (EU) 2016/425. The legislation lays down requirements for the design and manufacture of PPE that are necessary to allow these products to be sold and used in the EU market.

Gloves that have a medical purpose in the patient environment have to comply also with the applicable requirements of the Medical Devices Regulation (EU) 2017/745.

Other guidance is also available:

• PPE Regulation guidelines, which includes a categorization guide with examples.
• Conformity assessment procedures for protective equipment

Applicable standards

“Harmonised standards” exist in the EU for protective gloves. A product claiming a particular level of protection and complying with these standards is presumed to be in conformity with the essential health and safety requirements set out in the PPE Regulation if the standards are referenced in the Official Journal of the European Union (OJEU). Further information on, and the list of harmonised standards for PPE is available from here.

Note: The following site of CEN (the European standardisation organisation) provides links to the national standardisations bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

The following standards can be applied to protective gloves:

EN ISO 374-1:2016 and EN ISO 374-5:2016

This standard has been published in multiple parts and applies to protective gloves against dangerous chemicals and micro-organisms. Parts 1 and 5 relate to instructions for use, marking, packaging and performance requirements.

EN 388:2016+A1:2018

This standard outlines the performance requirements for gloves which are designed to protect against a range of mechanical risks.

EN 407:2004

This standard provides performance requirements and test methods for gloves which are designed to protect against thermal risks.

EN 420:2003+A1 2009

This is a general standard for protective gloves and provides a basis for assessment of protective gloves which do not have a specific standard related to the risks they are intended to protect against.

EN 511:2006

This is another general standard which has been developed to assess the effectiveness of gloves which are designed to protect the user against cold.

There are also other specific standards for protective gloves for use with chainsaws or with welding equipment, in environments with ionising radiation or electrostatic energy, those used by firefighters, those used in environments where sharp knives or stab risks are present, those designed to protect against vibration, and also those used by riders of motorcycles.

Other legislation of relevance:

While manufacturer’s need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) – restricts chemical substances in goods. REACH places responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database.
• Please note that every product must be safe for the consumers, according to the General Product Safety Regulation (GPSR) of the EU.

Mandatory labelling & warnings

The following are obligatory:

• CE Marking is obligatory for all PPE. If the gloves are considered to be category III PPE then the identification number of the notified body who was involved in the supervised product checks or in the assessment of the manufacturer’s quality system must be included after the mark. Before marking the PPE with the CE mark, the manufacturer needs to classify the product and identify all the applicable legal requirements, verify the conformity of the PPE with these requirements using the appropriate conformity assessment procedure (PPE category II and III requires the intervention of a notified body), compile a technical documentation that evidences this and create a written declaration of conformity. When this has been done, he should affix the CE mark on the product. Refer to the factsheet on CE marking. The NANDO information system, includes the list of available notified bodies per legislation and product category.
• Information on the manufacturer and the importer in the EU is obligatory.

In addition, the following information must be provided with the PPE:

1. Instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;
2. Performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE;
3. Where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;
4. Where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;
5. Where applicable, the month and year of period of obsolescence of the PPE or of certain of its components;
6. Where applicable, the type of packaging suitable for transport;
7. The significance of any markings;
8. The risk against which the PPE is designed to protect;
9. The reference to the PPE Regulation and, where applicable, the references to other Union harmonisation legislation;
10. The name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE;
11. References to the relevant harmonised standard(s) used, including the date of the standard(s), or references to other technical specifications used;
12. The internet address where the EU declaration of conformity can be accessed.

The information in points (i), (j), (k) and (l) need not accompany the product if it is supplied with a copy of the EU declaration of conformity.

General safety requirements

To ensure safety of protective gloves, there is also a range of general requirements to be fulfilled. These are explained in the following factsheets and need to be read in conjunction with this factsheet:

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate/RAPEX
• Selling online
• Technical documentation
• Testing
• Using a third party