Sustainability criteria for Disposable gloves for medical use | The National Agency for Public Procurement

Disposable gloves for medical use
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	Standards for the manufacture and inspection of disposable gloves	Core	Technical specification
Criterion information The production of disposable gloves in accordance with harmonised standards ensures compliance with directives and regulations regarding quality and safety. This requirement ensures that the end user is safeguarded from the risk or hazard that the gloves are intended to protect against, and that the disposable gloves offer the correct level of protection and are marked appropriately. Criterion text The following standards or the equivalent shall be met during the production of medical gloves for single use, examination gloves and surgical gloves: EN 455-1:2020+A1:2022 Medical gloves for single use - part 1: Requirements and testing for freedom from holes EN 455-2:2015 Medical gloves for single use - part 2: Requirements and tests for physical properties EN 455-3:2015 Medical gloves for single use - part 3: Requirements and tests for biological evaluation EN 455-4:2009 Medical gloves for single use - part 4: Requirements and testing for shelf life determination Medical gloves for single use shall be labelled with symbols in accordance with EN ISO 15223-1: 2021, see the annex regarding marking and information that shall be provided together with medical gloves for single use. Medical gloves for single use shall be tested in preclinical evaluation in accordance with: EN ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity), and EN ISO 10993-10:2023 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). The following harmonised standards shall be met during the manufacture of laboratory gloves (gloves for personal protection): EN 21420:2020 Protective gloves — General requirements and test methods EN 374-1:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016) EN 374-2:2019 Protective gloves against dangerous chemicals and micro-organisms - Part 2: Determination of resistance to penetration EN 16523-1:2015+A1 2018 Determination of material resistance to permeation by chemicals - Part 1: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact. EN 374-4:2019 Protective gloves against dangerous chemicals and micro-organisms - Part 4: Determination of resistance to degradation by chemicals. EN 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks Laboratory gloves shall be labelled in accordance with the requirements in EN 21420:2020 along with hazard symbols (pictograms), showing the protective function of the gloves for the specified risk. See the Marking of laboratory gloves with personal protection from chemicals annex.
	Pinhole defects (AQL) for disposable gloves	Advanced	Technical specification
Criterion information The purpose of this requirement is to allow gloves to be tendered with a higher standard for pinhole defects than the AQL set in standards within relevant areas, where a disposable glove with greater safety is needed. It is important to be able to ensure the quality of a glove's function and that it is safe to use, with the fewest possible defects. Criterion text Tendered products shall meet the following AQL levels: Surgical gloves shall achieve an AQL of 1.0 Examination gloves shall achieve an AQL of 1.5 Laboratory gloves shall achieve an AQL of 0.65
	Powder-free disposable gloves	Core	Technical specification
Criterion information The following requirements ensure that all disposable gloves are powder-free and that powdered gloves are not tendered. Criterion text All tendered disposable gloves shall be free from powder residues, and the amount of powder found in the gloves shall not exceed 2 mg/glove. The following test methods can be used for determining the amount of powder in all tendered disposable gloves: EN ISO 21171 (Medical gloves — Determination of removable surface powder) ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) Own analytical method (a description must be included)
	Substances for skincare in disposable gloves	Core	Technical specification
Criterion information This requirement ensures that gloves shall not be used as skincare products, because substances added to gloves can contribute to causing irritation or contact hypersensitivity to the gloves. Criterion text Substances intended to moisturise or soften the hands shall not be added to or included in the tendered products.
	Limitation of biocides (antimicrobial substances)	Core	Technical specification
Criterion information Products that are treated with biocides (antimicrobial function) contain substances that can be hazardous or toxic to humans and the environment and can accelerate the development of resistance in bacteria. Criterion text Disposable products shall not be treated with biocides – that is, treated with or deliberately containing one or more biocidal products¹.
	Limitation of phthalates (vinyl gloves)	Core	Technical specification
Criterion information Different types of chemicals are used for different types of glove. Plasticisers in gloves can increase their environmental impact as well as constituting a health risk, as documented for phthalates as a chemical group, which is based on the substance phthalic acid. Phthalates used as plasticisers in plastic – especially PVC (vinyl) – can be avoided by setting this requirement. Criterion text Phthalates, diesters of orthophthalic acid, in concentrations above 0.1 % by weight (1000 mg/kg) for each substance shall not be included in disposable polyvinyl chloride (PVC) gloves.
	Accelerator-free disposable gloves (nitrile)	Core	Technical specification
Criterion information Use of disposable gloves and laboratory gloves may lead to skin irritation and/or sensitisation to substances with contact allergenic properties. Thiurams, thiazoles and carbamates are accelerators and known contact allergens. It is therefore important that disposable gloves can be tendered that does not contain accelerators, and that can be used by staff with proven allergies. Criterion text The following groups of chemicals shall not be used in the manufacture of tendered accelerator-free disposable nitrile gloves: Accelerators or components known to form accelerators, such as thiurams, dithiocarbamates and thiazoles (see the Chemicals and allergens in the manufacturing of disposable gloves attachment)
	Primary and secondary packaging for disposable gloves	Core	Technical specification
Criterion information This requirement is set so that primary and secondary packaging shall be designed with appropriate materials for the disposable gloves to maintain the correct degree of purity (level of sterility for sterile gloves) to avoid contamination, and to reduce the environmental impact from the packaging materials. It is important that the primary and secondary packaging are labelled with relevant information and symbols to ensure correct protection and use of the gloves, in accordance with the guidance provided in the stated standards. It is also important that the secondary packaging is available in different sizes, to minimise the risk of wastage, which also applies if there is excess filling in the secondary packaging. Criterion text Packaging shall be sized so that no unnecessary packaging material us used and shall meet the requirements in Council Directive 94/62/EC on packaging and packaging waste. No packaging material shall contain PVC. Sterile medical Surgical gloves: The material used for the secondary packaging shall be a triple-layer sterile barrier system, with gloves individually packaged in sterile packaging bags in accordance with ISO 11607-1:2019/Amd 1:2023 (Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems) or the equivalent. The secondary packaging shall show information about the glove material, number of gloves contained and glove size, and secondary packaging shall be available in different sizes (from 100 pairs of gloves per secondary packaging). Marking with symbols on the primary and secondary packaging for sterile gloves (a sterile packaging bag for each pair of gloves) in accordance with EN ISO 15223-1 for medical gloves and EN 21420 for laboratory gloves, see the Marking and information that must be provided with medical gloves for single use and Marking of laboratory gloves with personal protection from chemicals attachments.
	Laboratory gloves with personal protection from chemicals	Core	Technical specification
Criterion information This requirement is set because it is important that gloves are suitable to protect from various hazards in laboratory or healthcare contexts, where greater protection is needed, and when gloves need to be extra resistant to chemicals, such as in connection with various treatments such as those involving cytostatics. Criterion text Laboratory gloves shall meet the requirements set for various protection classifications for chemicals and breakthrough times: The EN 16523-1:2015+A1 2018 Determination of material resistance to permeation by chemicals — Part 1: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact or equivalent. Breakthrough times for relevant substance classes and a selection of relevant substances for which the glove has been tested are shown in Annex A to the SS-EN 374-1 standard and for six different protection classes (in minutes). See the Marking of laboratory gloves with personal protection from chemicals supplement for further information. Cytostatic substances only: The ASTM D 6978-05 standard, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs or the equivalent.
	Sensitizing (allergenic) compounds in disposable gloves	Core	Special contract terms
Criterion information The use of disposable gloves can lead to irritation of the skin and/or sensitisation to substances with contact allergenic properties. It is therefore important to know which chemicals have been used in the manufacture of the tendered product and that constituent substances are declared. Criterion text At the start of the contract, the manufacturer shall specify the constituent substances that are either added during manufacture or are already known to be included in the product, such as accelerators or antioxidants that are known to cause health effects based on available data. See the Chemicals and allergens in the manufacturing of disposable gloves attachment
	Content of Substances of Very High Concern (Candidate List)	Core	Special contract terms
Criterion information Through this requirement, the contracting authority receives information on the content of chemicals hazardous to health or environment listed on the Candidate List in the EU chemicals legislation Reach. Criterion text For the duration of the contract, the supplier must be able to provide information on substances of very high concern as set out in the Candidate List in Article 59 of Regulation (EC) No 1907/2006 (REACH) at a concentration above 0.1% by weight (1,000 mg/kg) for each substance used in products covered by the contract. 0.1% by weight refers to each individual part of an item. The information must be provided in accordance with Article 33 of Regulation (EC) No 1907/2006 (REACH). Within 45 days of receiving a request from the contracting organisation, the supplier must present details of the existence of substances of very high concern used in the products. In its tender, the supplier must provide a short description of how it keeps information available about substances on the Candidate List that are used in the products, as well as its procedures for ensuring that the information is kept up to date.
	Climate impact of the product	Core	Award criteria
Criterion information The purpose of this requirement is to reward the suppliers who can obtain information about the climate impact of the products from a life-cycle perspective. Criterion text To be awarded [points/price deductions] in the tender evaluation the supplier shall be able to show the life-cycle climate impact for one or several disposable textiles, under the contract.
	Requirements under the ILO core conventions	Core	Special contract terms
Criterion information The contract terms on the basic level aim to ensure that the supplier has effective risk management regarding workers' rights under the ILO core conventions in its own operation as well as in the supply chain regarding subcontractors who are directly involved in the performance of the contract. Criterion text 1. The supplier's obligation Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding workers’ rights: The eight core conventions of ILO regarding forced labour, child labour, discrimination, freedom of association, and the right to collective bargaining (no. 29, 87, 98, 100, 105, 111, 138, and 182). The terms regarding workers’ rights are called “the Terms” hereafter. In the event of the core conventions of the ILO are in conflict with national law, the supplier shall take reasonable measures to ensure compliancy with the international regulations. The obligations concerns workers when they perform work within the frame of the contract. The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors that directly contribute to the performance of the contract, regardless of the number of intermediaries. In addition, the supplier shall ensure that these subcontractors participate in the follow-up, according to item 3. The obligations concerns work carried out under such conditions where Swedish labour law is not applicable. 2. Policies and routines To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied throughout the entire contract period in their own operation and the operation of any subcontractors who directly contribute to the performance of the contract, regardless of the number of intermediaries. At the start of the contract the supplier shall have: 2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms, 2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain, 2.3 appointed a manager at the highest management level, responsible for compliance with the Terms, 2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations, 2.5 adopted routines for regular follow-up of the Terms compliance, and 2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations. The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent. 3. Follow-up [The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit. 3.1 Self-assessment Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix. *3.2 Audit* The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit 4. Management of deficiencies If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority]. In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule. [The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established schedule. [The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms.
	Sustainable supply chains	Advanced	Special contract terms
Criterion information The terms regarding sustainable supply chains aim to ensure that the supplier has efficient risk management in their own operation and in the supply chain, covering the areas human rights, labour rights, environmental protection and anti-corruption. Criterion text 1. The supplier’s obligation Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding human rights, workers’ rights, environmental protection, and anti-corruption (sustainable supply chains): the UN Universal Declaration on Human Rights, the UN Convention on the Rights of the Child, Article 32, the eight core conventions of the ILO regarding forced or compulsory labour, child labour, discrimination, as well as freedom of association and the right to collective bargaining, (no 29, 87, 98, 100, 105, 111, 138, and 182), the labour law in force in the country were the work is performed, including regulations for salary, working hours, leisure time, and work environment, the environmental law in force in the country were the work is performed, and the UN Convention against Corruption. The terms regarding sustainable supply chains are called “the Terms” hereafter. When international regulations prescribe a stronger protection for the individual than the national legislation, the supplier shall take reasonable measures to ensure compliancy with the international regulations. The obligations concerns all operations connected to the performance of the contract. The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors in all parts of the supply chain. In addition, the supplier shall ensure that these subcontractors participate in the follow-up, according to item 3. 2. Policies and routines To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied concurrently throughout the entire contract period in their own operation as well as in the operation of any subcontractors in all parts of the supply chain. At the start of the contract the supplier shall have: 2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms, 2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain, 2.3 appointed a manager at the highest management level, responsible for compliance with the Terms, 2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations, 2.5 adopted routines for regular follow-up of the Terms compliance, and 2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations. The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent. 3. Follow-up [The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit. 3.1 Self-assessment Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix. 3.2 Audit The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit. 4. Management of deficiencies If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority]. In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule. [The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established schedule. [The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms.
	Disposable gloves made from chlorine-free plastic	Core	Technical specification
Criterion information The purpose of this requirement is to avoid plastics containing substances hazardous to the health and environment. By using this requirement, chlorinated plastic such as polyvinyl chloride is avoided for use in tendered disposable gloves for use in healthcare. Criterion text Disposable gloves shall not contain chlorinated plastics in concentrations exceeding 0.1% by weight¹ for each individual part of the consumable item.

Of all disposable items used in the health sector, disposable gloves represent the largest purchase volume. Gloves are used on many different occasions in healthcare, including during examinations, surgery and to protect healthcare workers from contamination. Disposable gloves are also used as protective equipment from chemical substances when working with disinfectants, cytostatic agents and medicines that may cause toxic effects, and shall therefore be tested to ensure that they prevent various chemicals used in healthcare from seeping through.

However, gloves may also cause irritant contact dermatitis or allergic dermatitis for the users. Substances used in the manufacture of rubber gloves can cause allergic contact dermatitis (type IV hypersensitivity), and protein residues can result in latex allergy. To minimise negative effects for the users, requirements for gloves need to be set high.

It is also recommended to follow the infection-control guidelines in the National Board of Health and Welfare's provisions on Basic hygiene in healthcare and care (SOFS 2015:10) and to use disposable gloves only when needed.

The sustainability criteria aim to improve the quality of disposable gloves that are procured for use in healthcare and thereby contribute to safe and sustainable use for individuals who use disposable gloves in their profession daily. They include requirements that the gloves shall be manufactured in accordance with current legislation and applicable EU standards, and that they shall be free from known allergens.

During procurement, it is important to clarify which gloves are included and to ensure that alternatives are available for use by workers who have developed allergies. It is also important to ensure that alternative laboratory gloves are made available as personal protective equipment suitable for work with chemicals. If examination gloves will also be used when handling food, it is important to check that these are tested for and intended to be used when handling food. The gloves shall be labelled with information confirming this in writing or with symbols (glass/fork).

Many regions and county councils have produced their own guidelines to aid healthcare workers in selecting the appropriate gloves for a given task.

Production involves major risks related to health and safety and the physical work environment, and most disposable gloves procured for use in healthcare are manufactured outside of the EU. The criteria will soon be supplemented with requirements regarding social conditions, in accordance with employment standards legislation.

Disposable gloves for medical use

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