Medical gloves are being imported into Europe in large quantities during the coronavirus pandemic. Importers need to be aware of the CE testing and regulations so they can import safe and correct gloves.
Page last updated: 1/6/20
1. What kinds of medical gloves can be imported into Europe?
According to the EU, medical gloves are ‘medical devices’ intended for use in the medical field to protect patients and users from cross-contamination. As medical devices, they must comply with the EU MD directive.
According to EN 455-2:2015 there are 3 classifications for medical-use gloves that are classed as MD and not PPE.
- Medical gloves for single use
Gloves intended for use in the medical field to protect patients and users from cross-contamination.
- Surgical gloves
Sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger rather than lying flat, and intended for use in invasive surgery.
- Examination gloves
Procedure gloves sterile or non-sterile medical gloves, which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostic and therapeutic procedures, and for handling contaminated medical material.
They are all fairly similar, but as you can see there are differences in design, usage, and whether they are sterile or not.
If you’re purchasing gloves for a government body or hospital trust, especially if they’re used by nurses and doctors who are treating patients, suppliers will likely offer you these.
Protective gloves (PPE)
Note: Single-use protective gloves may also be sourced and can be used by the general public, but these are NOT medical gloves to be used in the treatment of COVID-19. In addition, they are classified as PPE, not medical devices, and are regulated and tested differently. They are regulated under REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC.
2. What are single-use gloves made of and what colours can they be?
Both types of gloves may be available in white, clear, blue, pink, and purple depending on what your supplier produces, and are also made from a variety of different materials:
- Natural Rubber Latex (NRL)
Note: Powdered gloves may occur in the EU – in the case of powdered surgical gloves, EN455-3 states:
“CAUTION: Surface powder shall be removed aseptically prior to undertaking operative procedures in order to minimize the risk of adverse tissue reactions”
3. Regulations and performance testing for medical gloves & protective gloves
All products imported for use in Europe should bear a CE mark.
In the case of gloves, they must comply with the correct regulations before they will be granted the CE mark. An important element of compliance will be the passing of relevant performance tests.
As an importer, you should not only check that a supplier holds legitimate CE certification, but should also check the testing report to see that the product/s you’re purchasing has actually passed.
Medical gloves are regulated under the medical device directive (MDD93/42/EEC) as Class I MD (non-invasive). Note: This will be replaced by the new Medical Device Regulation 2017/745 (MDR) on 26/5/21, so your familiarity with that regulation will be helpful.
The key types are surgical gloves and examination gloves, and you can see their regulatory information below:
These harmonized standards will be used by the testing bodies for the medical gloves:
- EN 455-1 – Medical gloves for single use – Part 1: Requirements and testing for freedom from holes – the gloves are filled with water and checked for leakage in order to assess that they have no holes.
- EN 455-2 – Medical gloves for single use – Part 2: Requirements and testing for physical properties – classifies the gloves and tests their dimensions and strength.
- EN 455-3: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation – evaluates the gloves’ biological safety and absence of proteins, endotoxins, and powder adhering to the general principles of ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process and ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.
- EN 455-4: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination – assesses whether the gloves will comply with the various EN 455 standards (and sterility if applicable) for the entire duration of their shelf lives by using accelerated stability studies to simulate aging.
Sterility (some of these standards will only apply to surgical gloves, and/or examination gloves sold as sterile)
- BS EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices
- ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
- ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 11607-1:2020 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems – used for gloves which are sold as sterile, this standard evaluates the sterility of the packaging.
Protective gloves are tested to comply with the EU PPE Directive, and the following performance tests:
- EN ISO 21420:2020 Protective gloves. General requirements and test methods
- BS EN 388:2016+A1:2018 Protective gloves against mechanical risks
- BS EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms (note: there are 5 parts to EN 374 – Part 1: Terminology and performance requirements for chemical risks, Part 2: Determination of resistance to penetration, Part 3: Determination of resistance to permeation by chemicals, Part 4: Determination of resistance to degradation by chemicals, and Part 5: Terminology and performance requirements for micro-organisms risks)
4.The CE Certification Process
The process to gain the CE mark which allows gloves to be imported and sold in Europe according to EU MD directive is as follows:
- Determine medical device (MD) classification (Class I or II).
- Choose conformity assessment procedure conforming with harmonised European standards (EN 455: 1-4 etc) OR another verified technical specification.
- Select Notified Body (not required for Class I MD unless sold as sterile) – this organisation will perform the lab testing.
- Implement Quality Management System (QMS) – If the manufacturer is ISO 13485 certified for medical devices this will usually assure safety & quality, however, an appropriate but non-certified QMS is acceptable, too.
- Prepare Technical File (TF) or Design Dossier – Includes bill of materials (BOM), design drawings, label files, packaging files, list of applicable EN standards or directives (such as EN 455: 1-4 etc), laboratory test reports, product QC inspection reports, risk assessment.
- Appoint an Authorized EC Designated Representative (for non-European suppliers).
- Audit by Notified Body of QMS and TF (not required for Class I MD unless sold as sterile).
- Register medical device – the product must be registered with the national authority of the country where it is to be imported to and sold because it is a medical device.
- Manufacturer prepares Declaration of Conformity (DoC) – This self-declaration includes SKU, product features, user manual, contact details of manufacturer/importer, list of applicable EN standards or directives (such as EN 455: 1-4 etc), manufacturing location, name of responsible individual.
The EU provides a thorough guide to drawing up your EC DoC.
- Affix CE mark – This will be on the product labelling and its packaging. You can read CE marking regulations here.
- (IF product is STERILE) – the product’s labelling and packaging will also include the word STERILE and the product MUST be tested by a notified body regardless of whether it is a Class I or Class II MD.
The route to CE certification for PPE is as follows:
Realistically, protective single-use gloves are going to be Category I or II PPE. The remaining requirements are outlined in the annexes of the PPE REGULATION (EU) 2016/425 and will vary based on the category of PPE as shown in the diagram above.
- Classify PPE category
Category I: PPE intended to protect users against minimal risks: (superficial mechanical injury / contact with cleaning materials of weak action or prolonged contact with water / contact with hot surfaces not exceeding 50 °C / damage to the eyes due to exposure to sunlight (other than during observation of the sun) / atmospheric conditions that are not of an extreme nature.
Category II: Equipment falling into neither Category I or Category III.
Category III: PPE intended to protect users against very serious risk such as death or irreversible damage to health: (substances and mixtures which are hazardous to health / atmospheres with oxygen deficiency / harmful biological agents / ionising radiation / high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C / low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less / falling from a height / electric shock and live working / drowning / cuts by hand-held chainsaws / high-pressure jets / bullet wounds or knife stabs / harmful noise). (Annex 1)
- Create technical documentation
Shows conformity of PPE with health & safety requirements for its eventual use. Includes: PPE description, risk assessment, health & safety requirements, instructions for use, technical drawings, harmonised standards adhered to, and more (Annex 2&3)
- EU type examination
A notified body checks the technical documentation and tests the PPE for compliance and safety and provides an examination certificate – only applies to category II & III PPE. (Annex 5)
- Classify PPE category
- Conformity to type based on internal production control plus supervised product checks at random intervals OR on Quality Assurance of the production process
A notified body checks the manufacturer’s production system and/or quality system to check that production is compliant and consistent with what is outlined in the technical documentation. (Annex 6&7)
- EU declaration of conformity
The PPE declaration of conformity is signed by the manufacturer and includes:
5. Medical gloves FAQs for EU importers
- Yes, not all PPE products must be CE-certified right now and the European commission has issued a recommendation to speed up supply. It is possible to import non-CE marked PPE as long as it:
a) adheres to a relevant harmonised European standard, or
- b) any of the standards referred to in the WHO guidelines or,
- c) any other non-EU standard or technical solution, provided that the specific solution ensures that the product complies with the applicable essential health and safety requirements.
Importers must still consider their liability should they choose to import non-CE certified PPE into Europe.
Probably not. Due to the demand, testing labs are swamped and are giving lead times of several months for certain tests. During the coronavirus pandemic when you need goods now, running new lab tests is probably unrealistic.
Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:
- Due diligence on suppliers before placing orders – are they legitimate manufacturers, are they legal?
- Certificate verification – is their certification real? Are the documents they provide for the correct products?
- Factory audits – this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
- Product inspections – gives you the security that your products are good quality before they are shipped.
No, but it will go a good way. It is still important to check whether the supplier truly holds these certifications with the issuing bodies and also continually check product compliance and quality through factory auditing and product inspections.
Medical gloves for single use or examination gloves should be adequate for treating COVID-19 patients (check with your country’s government for specific rules on this), whereas the general public would be better served by using ‘protective gloves’ for everyday purposes.
The EU has created this helpful guide demonstrating how to legally place medical devices and PPE on the EU market, and therefore safely purchase and use them, too.
It explains the procedure for legally placing markets for sale, what a certificate of conformity should include, what testing reports are, and much more.
Remember, importers of medical devices and PPE can be held responsible for illness or injury caused when using the products if it’s found that they were not compliant with the correct EU regulations, therefore understanding the legalities is important.
Sofeast’s indemnity and notes for the reader
- We are not legal professionals and any information provided here about the regulations and standards is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
If you are unsure about the validity of your products, please refer to the EU’s official documentation, an accredited testing body, or a local legal professional for assurance before importing MD or PPE from China to Europe.
- This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.