EN 455 – Medical Gloves for Single Use is the European standard defining safety, quality, and compliance requirements for disposable medical gloves. Below you’ll learn what EN 455 covers, who it applies to, and where to access the official standard legally.
What Is EN 455?
EN 455 is a set of harmonized European standards covering single-use medical gloves (examination and procedure gloves). It ensures gloves meet strict requirements for safety, hygiene, barrier integrity, and biological compatibility.
Key Parts of the EN 455 Series
- EN 455-1: Requirements and testing for freedom from holes — ensures gloves have no pinholes or microscopic leaks.
- EN 455-2: Tests physical properties (dimensions, strength, elasticity) before and after ageing.
- EN 455-3: Biological evaluation — ensures gloves are safe for contact with skin/patients (low allergenic potential, safe residual chemicals).
- EN 455-4: Requirements for shelf-life determination — ensures gloves maintain safety and barrier function until expiry.
- EN 455-5: Testing for extractable chemical residues — ensures no harmful chemicals remain in gloves.
Why EN 455 Compliance Matters
- Ensures gloves provide a reliable barrier against microbes, fluids, and contaminants — critical for patient and user safety.
- Required for CE marking and compliance with medical-device or PPE regulations in the EU.
- Guarantees gloves maintain quality over shelf-life and use — important for hospitals, labs, and medical suppliers.
- Provides legal and audit-ready documentation — crucial for tender offers, procurement, and compliance review.
Who Must Use EN 455-Compliant Gloves?
This standard applies to any manufacturer, supplier, distributor, or user of single-use medical gloves — including healthcare facilities, laboratories, dental clinics, pharmaceutical companies, and any setting requiring sterile or hygienic single-use gloves.
Access the Official EN 455 Standard
Below you can search, view, or buy the official EN 455 standard from an authorized provider:
FAQ: EN 455 – Medical Gloves for Single Use
What does EN 455 cover?
EN 455 series covers hole-free integrity, physical strength, biological safety, shelf-life, and chemical safety of single-use medical gloves.
Are EN 455 gloves mandatory?
For medical gloves sold or used as medical devices in the EU, compliance with EN 455 is mandatory to meet safety and regulatory requirements.
Can non-compliant gloves be used in healthcare?
No. Non-compliant gloves may fail barrier integrity, hygiene, or safety tests and risk endangering patients or users. Use only EN 455-certified products.
Do EN 455 standards need to be purchased?
Yes. Official EN 455 documents are copyrighted and must be legally acquired for compliance, documentation, and audit proof.