Glove Regulations and Safety Standards in the EU

Gloves sold in the EU are subject to various regulations, standards, labelling and chemical restrictions. That said, the compliance requirements differ depending on the type of glove. In this guide, we take a closer look at the requirements for gloves under the PPE regulation, GPSR, REACH, and other EU regulations and directives.

• Protective gloves generally require CE marking
• Gloves for consumers are covered by the GPSR
• MDR covers medical gloves
• Substance restrictions apply to glove materials

Protective Gloves (PPE)

Gloves with a protective function are generally covered by the PPE regulation, which mandates CE marking and compliance with standards, labelling and documentation requirements.

• Work gloves
• Protective sport gloves
• Cut resistant gloves
• Chemical resistant gloves
• Heat resistant gloves
• Cold resistant gloves
• Welding gloves
• Electrical insulating gloves

PPE category

Gloves and other protective equipment are divided into three separate risk categories. The category, in turn, decides which conformity assessment procedure you must follow.

PPE Category	Glove examples*	Conformity assessment procedure
Category I	1. Gloves designed to protect against cleaning materials of weak action (e.g. for dishwashing, cleaning) 2. Equipment designed to protect against mechanical action with superficial effects (e.g. pricks due to sewing, gardening, dirty work, and some sports) 3. Equipment designed to protect against heat (less than 50 °C), unexceptional cold weather, or dangerous impacts 4. Gloves designed for skin protection against natural UV radiation	Internal production control (module A)
Category II	1. Equipment and accessories designed to protect arms and hands (e.g. gloves, fingerless gloves, mittens) that protect from risks not covered by products listed in category I or III 2. Dry gloves for divers 3. Protective gloves against heat for private use (e.g. oven gloves and mittens) 4. Motorcyclist gloves 5. Gloves designed for skin protection against artificial UV radiation	EU type-examination (module B) and conformity to type based on internal production control (module C)
Category III	1. Gloves designed to protect against electrical shock (e.g. welder gloves) 2. Gloves designed to protect against high temperatures (e.g. welder gloves, fire-fighter gloves) 3. Equipment designed to protect against low temperatures (e.g. air temperature of -50 °C or less) 4. Equipment designed to provide limited protection against hazardous substances and mixtures, harmful biological agents or ionising radiation (e.g. single-use gloves for hairdressers)	EU type-examination (module B) and one of the following two: a. Conformity to type based on internal production control plus supervised product checks at random intervals (module C2), or b. Conformity to type based on quality assurance of the production process (module D)

Note: The category for gloves and finger guards for medical use in the patient’s environment depends on the type of protection that they are intended to provide.

*Based on the PPE Regulation Guidelines – Guide to application of Regulation EU 2016/425 on personal protective equipment

Glove standards

Gloves are only deemed to be compliant with the PPE regulation if certain product standards are met. The following EN standards are harmonised under the regulation and mention gloves:

EN ISO 374-1 – Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risk

EN ISO 374-5 – Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)

EN 388 – Protective gloves against mechanical risks

EN 407 – Protective gloves against thermal risks (heat and/or fire)

EN 420 – Protective gloves – General requirements and test methods

EN 421 – Protective gloves against ionizing radiation and radioactive contamination

EN 511 – Protective gloves against cold

EN 659 – Protective gloves for firefighters

EN 1082-1 – Protective clothing – Gloves and arm guards protecting against cuts and stabs by hand knives – Part 1: Chain mail gloves and arm

EN 1082-2 – Protective clothing – Gloves and arm guards protecting against cuts and stabs by hand knives – Part 2: Gloves and arm guards made of material other than chain mail

EN ISO 10819 – Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013

EN ISO 11393-4 – Protective clothing for users of hand-held chainsaws – Part 4: Performance requirements and test methods for protective gloves (ISO 11393-4:2018)

EN 12477 – Protective gloves for welders

EN 13594 – Protective gloves for motorcycle riders – Requirements and test methods

EN 14328 – Protective clothing – Gloves and armguards protecting against cuts by powered knives – Requirements and test methods

EN 16027 – Protective clothing – Gloves with protective effect for association football goal keepers

EN 16350 – Protective gloves – Electrostatic properties

These standards have a direct impact on how the glove must be designed, and the materials that must be used. For example, cut resistant gloves must:

a. Ensure that the wearer is sufficient covered

b. Made of a sufficiently strong material

Documentation

Glove manufacturers must compile or obtain a set of documents to ensure compliance with the PPE regulation.

Document	PPE Category	Part
Declaration of Conformity	All	Annex IX
Technical documentation	All	Annex III
Instructions	All	Annex II – 1.4
Register of complaints, of non-conforming PPE and PPE recalls	All	Article 8, Article 10
EU type examination certificate	Category II and III	ANNEX V

Labelling

CE marking is required for essentially all protective gloves in the EU. Further, the following information must also be present (as applicable):

• Product type, batch or serial number
• Manufacturer name
• Manufacturer address
• Importer name (if any)
• Importer address (if any)
• Notified body number (if any)

Note that standards can also contain additional marking and labelling requirements for gloves.

Other Gloves

Not all gloves are protective, and thus not covered by the PPE regulation. That said, certain regulations apply to consumer products and are therefore also relevant to gloves.

General Product Safety Regulation (GPSR)

The General Product Safety Regulation (GPSR) requires that all products sold in the EU are fundamentally safe for the consumer. In practice, you may need to take the following steps to comply with the GPSR:

✅ Identify relevant EN standards (if any)

✅ Affix traceability labelling

✅ Create instructions

✅ Risk assessment and technical documentation

✅ Arrange third-party testing

Textiles Labelling Regulation

The EU Textiles Labelling Regulation requires that products containing at least 80 % by weight of textile fibres carry a fibre composition label. Examples are provided for context:

• 100% cotton
• 100% polyester
• 70% cotton 30% polyester

Certain exemptions are mentioned for the following types of gloves:

Glove	Exemption
Oven gloves	Labelling or marking is not mandatory (Annex X)
Washgloves	Inclusive labelling is sufficient (Annex VI)

EU Deforestation Regulation (EUDR)

The EU Deforestation Regulation (EUDR) sets requirements for some products that are made or contain certain commodities, including rubber, wood, and more.

Specifically, it covers products listed in Annex I. This includes gloves, mittens, mitts and other articles of apparel and clothing accessories, for all purposes, that are made of vulcanised rubber other than hard rubber.

As such, if your gloves contain rubber, you may need to comply with requirements such as:

✅ Due diligence (e.g. information requirements, risk assessment and mitigation measures

✅ Due diligence statement

✅ Registration

Medical gloves

The Medical Devices Regulation sets safety and other requirements for medical devices. In particular, devices are divided into classes I, IIa, IIb and III, according to their intended purpose and inherent risks. The requirements may vary according to the product classification.

While the regulation provides criteria for classification, it does not mention “gloves”. Having said that, the document “Guidance on classification of medical devices” available on the EU website provides the following information:

• Examination gloves: Class I
• Surgical gloves: Class IIa (as they are deemed surgically invasive)

Here are some of the main requirements set by the Regulation:

✅ Product classification

✅ Identification of relevant EN standards (if any) and other safety requirements

✅ Labelling (e.g. CE marking, traceability information, Unique Device Identification)

✅ Risk assessment

✅ Documentation (e.g. Technical documentation, Declaration of Conformity)

✅ Claims

✅ Instructions

✅ Product testing

As said, the specific requirements may vary according to the product classification.

Substance Regulations

Various EU regulations on chemicals in heavy metals in materials used to manufacture gloves and other products. The table below provides an overview:

Regulation	Relevancy
REACH Regulation	Restrict DEHP, lead, cadmium, AZO dyes and other substances that can be found in plastic and textile materials used to manufacture gloves.
POPs Regulation	Restrict persistent organic pollutants, such as PFAS. Pesticides can sometimes contaminate textile materials used to manufacture gloves.
Biocidal Products Regulation	Regulates biocidal products and articles treated with biocidal products. This could, for example, include gloves treated with disinfectants covered by the regulation.

FAQ

Is CE marking required for all gloves?

CE marking is required for protective gloves which are covered by the PPE regulation. Note that not all gloves have a protective function.

Is CE marking required for gardening gloves?

Yes, if the gardening gloves have a protective function, then these are likely subject to the PPE regulations, which require CE marking.

Is CE marking required for dishwashing gloves?

The PPE regulation states the following:

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As for products intended for private use to protect against atmospheric conditions that are not of an extreme nature or to protect against damp and water, including but not limited to seasonal clothing, umbrellas and dishwashing gloves, those should also fall outside of the scope of this Regulation. It is also appropriate to clarify the list of excluded PPE set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore excluded from the scope of this Regulation.

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In this context, it is clear that dishwashing gloves for private use are not covered by the PPE regulation and would likely not require CE marking as a result.

That said, it does not mention that dishwashing gloves used in a commercial setting (i..e, restaurants or hotels) are exempt. Hence, dish washing gloves (and other gloves for that matter) used in a commercial setting may require CE marking whereas the same product made for private use would not.

Note that this is likely only the case for certain products. Many gloves intended for private use still have a protective function and must therefore be CE marked.

Is textile labelling required for gloves?

Yes, textile labelling is generally required for gloves made of textiles. Note that certain types of gloves are subject to exemptions.