EN 455 – Medical Gloves for Single Use is the mandatory European standard suite defining the safety, quality, and performance of disposable medical gloves. Compliance with EN 455 is essential for meeting the EU Medical Device Regulation (MDR) and ensuring patient safety in clinical environments.
What Is EN 455?
EN 455 specifies the requirements for single-use gloves (examination and surgical) to ensure they provide an effective barrier against cross-contamination. Unlike PPE standards (which protect the wearer), EN 455 focuses heavily on protecting the patient from contamination.
The 4 Parts of the Standard
Manufacturers must demonstrate compliance with all relevant parts of the series to CE mark their product as a medical device:
EN 455-1: Freedom from Holes
Tests for water-tightness using a water leak assay. This establishes the AQL (Acceptable Quality Level).
EN 455-2: Physical Properties
Defines dimensions (length/width) and Force at Break (strength) to ensure gloves don’t tear during use.
EN 455-3: Biological Evaluation
Limits for chemicals, endotoxins, powder residue, and leachable proteins (latex) to prevent allergies.
EN 455-4: Shelf Life
Real-time and accelerated aging tests to prove the glove remains effective until its expiration date.
Critical Concept: What is AQL 1.5?
For medical examination gloves, EN 455-1 mandates an Acceptable Quality Level (AQL) of 1.5 or lower. This is a statistical measurement derived from ISO 2859-1.
- ✅ AQL 1.5 means that in a statistical sample, less than 1.5% of gloves may fail the water-tightness test (pinholes).
- ✅ If a batch exceeds this failure rate, the entire production batch is rejected.
- ✅ Note: Surgical gloves often require an even stricter AQL (e.g., 0.65).
EN 455 (Medical) vs. EN 374 (PPE)
Buyers often confuse these two. It is possible for a glove to be dual-certified, but the distinction is vital:
| Standard | Regulation | Primary Purpose |
|---|---|---|
| EN 455 | Medical Device Regulation (MDR) | Protect the Patient (from infection). |
| EN 374 | PPE Regulation | Protect the User (from chemicals/viruses). |
How to Achieve EN 455 Compliance
- Purchase the Standards: You must own the official EN 455 parts (1-4).
- Laboratory Testing: Send samples to an accredited lab to test for pinholes (Part 1), dimension/force (Part 2), and protein levels (Part 3).
- Aging Studies: Perform accelerated aging tests (Part 4) to determine shelf life (e.g., 3 or 5 years).
- Technical File: Compile all test reports into your Technical Documentation for the Declaration of Conformity.
📥 Access the Official EN 455 Standards
Ensure your test methods and quality levels meet the latest 2024/2025 requirements. Download the official documents from Genorma.
⚠️ Official PDF Standards starting from €68.00
Available in PDF and Hardcopy formats.
Frequently Asked Questions
Is EN 455 mandatory?
Yes. If you market gloves as “Medical Examination Gloves” in the EU, they must comply with EN 455 to obtain CE marking under the Medical Device Regulation (MDR).
Does EN 455 cover protection against chemicals?
No. Protection against chemicals and dangerous microorganisms is covered by EN ISO 374. EN 455 focuses on the glove’s integrity and safety for the patient.
What is the shelf life requirement in EN 455-4?
EN 455-4 requires manufacturers to validate shelf life (typically 3 to 5 years) through real-time stability studies. Accelerated aging can be used for initial launch, but real-time data must follow.
Do I need to buy the official standard?
Yes. Testing laboratories and Notified Bodies require you to base your testing protocols on the officially licensed version of the standard.