Disposable gloves for medical use

The tenderer of the tendered products shall report procedures for systematic quality management, and shall have documented procedures and instructions in place for ensuring:

• That the requirements for tendered products are checked and fulfilled during the contract period
• That documentation to verify fulfilment of the requirements is available
• That there is a contact person with respect to the contracting authority

To ensure compliance with the points above, the procedures and instructions shall cover at least the following:

1. Monitoring and record-keeping (e.g., regular checks of raw material- and product quality)
2. Reporting and correcting deviations from the requirements that have been set
3. Reporting and documenting production changes for the tendered products
4. Reporting, documenting, and handling claims and complaints regarding the tendered products
5. Traceability throughout the entire supply chain

• 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.

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  

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 intended to moisturise or soften the hands shall not be added to or included in the tendered products.

Disposable products shall not be treated with biocides – that is, treated with or deliberately containing one or more biocidal products¹.

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.

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)

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 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.

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.

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

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.

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.

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 andmanage 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.