Standards for the manufacture and inspection of disposable gloves
Level: Core
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.
Details
- Type:
- Technical specification
- ID:
- 11197:1
- Group:
- Disposable gloves for medical use
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.
Verification
For medical gloves for single use
Product data sheets verifying that the medical gloves for single use have been tested in accordance with EN ISO 10993-5 and EN ISO 10993-10.
and
Examination gloves, medical devices, class I: CE marking (EU declaration of conformity) verifying that the examination gloves meet the requirements set out in EN 455
and
Surgical gloves, medical device, class IIa: CE marking (EU declaration of conformity and EC certificates from an accredited independent party) verifying that the surgical gloves meet the requirements set out in EN 455, or
For medical examination gloves and surgical gloves that also meet the requirements set out in Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment, or Regulation (EU) 2016/425 on personal protective equipment: CE marking (EU declaration of conformity and EC certificate from an accredited independent organisation), together with the relevant hazard symbols (pictograms),
or
Laboratory gloves: CE marking (EU declaration of conformity and EC certificate from an accredited independent organisation) together with relevant hazard symbols (pictograms).
Marking in accordance with symbols on the primary and secondary packaging for sterile gloves in accordance with EN ISO 15223–1 for medical gloves, and EN 42020:20 for laboratory gloves.
The supplier’s self-declaration, including technical documentation of compliance, shall be verified by an accredited verification body that is accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Check for CE marking and ensure that certificates from accredited independent organisations are valid for the duration of the contract period. Certificates commissioned from a declared accredited body must be issued to the company that manufactures the tendered product.
Check that the relevant information is shown on the gloves' packaging as well as the primary and secondary packaging for sterile gloves.
Ask the manufacturer for test reports with the relevant batch number. The test reports shall contain at least information about AQL, strength, size and length of the gloves.
If needed, request the technical documentation connected with the regulations/stated legislation.
Self-declaration verified by an accredited verification body
If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.
Information about the criterion
This requirement ensures that gloves are safe to use because they have been tested in accordance with standards that relate to the field of application stated in the specifications/Safety Data Sheet, and the supplier shall be able to prove compliance with relevant standards.
Different standards apply for each type of disposable glove, and it is possible to get gloves that only satisfy the requirements in either the Medical Devices Directive or the Personal Protection Directive, or gloves that meet the requirements in both directives if extra protection is needed.
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Environmental goals
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11197:1
- Version date
- 2024-03-15
- Review date
- 2022-04-06