EN 455-3:2023/FprA1
(Amendment)Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
- Abstract
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
- Status
- Not Published
- Publication Date
- 24-Feb-2027
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 3 - Medical gloves
EN 455-3:2023/FprA1 is a CEN draft amendment to EN 455-3:2023 for medical gloves for single use. It updates the requirements and testing used for biological evaluation, with added focus on chemicals, leachable chemicals, proteins, endotoxins and labelling. It is written for glove manufacturers, test laboratories and teams that prepare technical documentation and conformity evidence.
What does EN 455-3:2023/FprA1 specify?
EN 455-3:2023/FprA1 amends the part of EN 455 that deals with biological evaluation of medical gloves for single use. It keeps the document centered on safety-related evaluation and on the information that must accompany test results and product claims.
| Part of the document | What it covers |
|---|---|
| Clauses 1-8 | Normative references, terms and definitions, chemicals, leachable chemicals, endotoxins, powder-free gloves, proteins and labelling |
| Annex ZA | Relationship with Regulation (EU) 2017/745 and the correspondence table |
The foreword also places this document in the EN 455 series, alongside Parts 1, 2, 4 and 5. That matters because the biological evaluation in Part 3 points into Part 5 for chemical residue methods and examples.
What are the key requirements of EN 455-3:2023/FprA1?
Clause 4.2 keeps the focus on chemical ingredients in gloves and replaces the wording “talcum powder” with “powdered talc”. The note explains that ingredients such as curing agents (vulcanising agents), accelerators, stabilisers, surfactants, antioxidants, plasticisers and biocides can cause adverse health effects. In practice, manufacturers need to know which process chemicals can remain in the glove and how those residues are described to users.
Leachable chemicals and evidence
Clause 4.3 is new and is one of the main technical changes. EN 455-3:2023/FprA1 requires the manufacturing process to aim to minimize the leachable chemical level, and it requires the leachable potentially allergenic chemical content in finished gloves to be assayed by the method in EN 455-5:2025.
That result has to be documented and retained, and the test result plus the assay method must be made available on request. For a manufacturer, this means the chemical-control file and test record are part of the product evidence, not just internal notes.
Endotoxins, powder-free gloves and proteins
Clause 2 updates the normative reference to the European Pharmacopoeia, 11th edition, General chapter 2.6.14 Bacterial Endotoxins. Clause 4.4 and the powder-free glove wording are adjusted by renumbering, and Clause 4.6 is retitled “Leachable proteins”.
In practice, the amendment keeps the biological evaluation tied to endotoxin control, powder residues and protein-related assessment. Those topics matter because they affect product claims, testing plans and how a glove is described in technical documentation.
Labelling and product claims
Clause 4.7 adds a restriction on claims about extractable chemical content when the analytical methods have not been fully validated and verified. It also requires, for any claim about leachable chemical content, information on the chemical name and the process limit, with the process limit measured by the method in EN 455-5:2025.
That means packaging and accompanying information must be specific enough for a buyer, user or auditor to compare the claim with the measured data. Vague chemical claims are not enough.
EU conformity link
Annex ZA is replaced and links the standard to Regulation (EU) 2017/745. The table in Annex ZA shows which clauses partially cover selected General Safety and Performance Requirements and explains where the standard can support a presumption of conformity when cited in the Official Journal of the European Union.
What terms does EN 455-3:2023/FprA1 define?
- chemical - a substance added or formed during manufacturing, sterilisation or storage that can be present in the final product; this is the term used for residual process chemicals in gloves.
- leachable - a substance released from a medical device or material during clinical use; this is the basis for the new leachable chemical requirement.
- allergenic proteins - the term used in the protein-related clause to describe proteins relevant to allergic risk.
- leachable proteins - the renamed protein term used for proteins that can be released from the glove and assessed in the biological evaluation.
- powder-free gloves - the glove category covered by the powder-free clause and its residue-related checks.
- endotoxins - bacterial endotoxins referenced for biological evaluation through the pharmacopoeial method.
Who uses EN 455-3:2023/FprA1?
Manufacturers of single-use medical gloves use EN 455-3:2023/FprA1 when designing the glove, selecting materials and writing claims. Test laboratories use it for chemical, protein and endotoxin-related assays. Quality, regulatory and conformity assessment teams use it to build technical files, review labels and check whether product information matches the test evidence.
What changed in EN 455-3:2023/FprA1 from the previous edition?
EN 455-3:2023/FprA1 modifies EN 455-3:2023. The amendment:
- adds EN 455-5:2025 to the normative references and updates the endotoxin reference,
- adds definitions for chemical and leachable and updates the protein terminology,
- adds Clause 4.3 on leachable chemicals,
- tightens the labelling rules for chemical-content claims,
- replaces Annex ZA with an updated link to Regulation (EU) 2017/745.
Which standards are used with EN 455-3:2023/FprA1?
- EN 455-5:2025 - provides the method for assaying leachable potentially allergenic chemical content and the chemical naming reference used in labelling.
- European Pharmacopoeia, 11th edition, General chapter 2.6.14 Bacterial Endotoxins - supplies the endotoxin reference used in the document.
- EN ISO 10993-18:2020 - is the source named for the definition of leachable.
- EN 455-1, EN 455-2, EN 455-4 and EN 455-5 - are named as the other parts of the EN 455 series for medical gloves for single use.
What does the EN 455-3:2023/FprA1 document contain?
EN 455-3:2023/FprA1 contains clause-by-clause amendments, not a full reissue of the base standard. It changes normative references, definitions, chemical and protein wording, and the labelling clause, so it is used when drafting test plans, product claims and technical documentation. Annex ZA provides the correspondence table for EU regulatory use, which is relevant for conformity assessment and regulatory audits.
Relations
- Effective Date
- 05-Jun-2024
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 455-3:2023/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 3: Requirements and testing for biological evaluation". This standard covers: This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
EN 455-3:2023/FprA1 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 455-3:2023/FprA1 has the following relationships with other standards: It is inter standard links to EN 455-3:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-3:2023/FprA1 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575, M/575 Amd 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 455-3:2023/FprA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za
biološko ovrednotenje - Dopolnilo A1
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2023/prA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
EN 455-3:2023
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
September 2025
ICS 11.140
English Version
Medical gloves for single use - Part 3: Requirements and
testing for biological evaluation
Gants médicaux non réutilisables - Partie 3 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour évaluation biologique Teil 3: Anforderungen und Prüfung für die biologische
Bewertung
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 455-3:2023. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2023/prA1:2025 E
worldwide for CEN national Members.
EN 455-3:2023/prA1:2025 (E)
Contents Page
European foreword . 3
1 Modification to Clause 2, “Normative references” . 4
2 Modification to Clause 3, “Terms and definitions” . 4
3 Modification to 4.2, “Chemicals” . 4
4 Addition of 4.3, “Leachable chemicals” . 5
5 Modification to 4.4, “Powder-free gloves” . 5
6 Modification to 4.5, “Proteins, leachable” . 5
7 Modification to 4.6, “Labelling” . 5
8 Modification to Annex ZA . 5
EN 455-3:2023/prA1:2025 (E)
European foreword
This document (EN 455-3:2023/prA1:2025) has been prepared by Technical Committee CEN/TC 205
“Non-active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
EN 455 consists of the following parts under the general title “Medical gloves for single use”:
— Part 1: Requirements and testing for freedom from holes;
— Part 2: Requirements and testing for physical properties;
— Part 3: Requirements and testing for biological evaluation;
— Part 4: Requirements and testing for shelf life determination;
— Part 5: Extractable chemical residues.
A list of all parts in a series can be found on the CEN website.
EN 455-3:2023/prA1:2025 (E)
1 Modification to Clause 2, “Normative references”
Add the following normative reference:
“EN 455-5:2025, Medical gloves for single use — Part 5: Extractable chemical residues”
Change the following reference to become:
th
“European Pharmacopoeia, 11 edition, General chapter 2.6.14 Bacterial Endotoxins: publisher EDQM -
Council of Europe; 7 allée Kastner, CS 30026, F-67081 Strasbourg; France http://www.edqm.eu/”
2 Modification to Clause 3, “Terms and definitions”
Update the reference in Note 1 to entry of term 3.4 from “see 4.4” to “see 4.5”.
Replace term 3.6 “proteins, allergenic” with “allergenic proteins”.
Replace term 3.7 “proteins, leachable” with “leachable proteins”.
Add the following terms and definitions:
“
3.9
chemical
substance added or formed during any step of the manufacturing process, including sterilisation, or in
storage which can be available in the final product
Note 1 to entry: These can include but are not limited to lubricants, chemical coatings and sterilizing agents.
Several chemical ingredients are commonly used during processing of gloves, some of them are known to cause
Type IV allergic reactions. The type and amount of residual chemicals added and finally present are variable.
[SOURCE: EN 455-5:2025, 3.2]
3.10
leachable
substance that is released from a me
...