Medizinischer Handschuh
Medical glove is the umbrella term for single-use gloves intended for medical use and placed on the market as medical devices under MDR (EU) 2017/745. They must comply with the EN 455 standard series.
Classification:
1. Examination gloves: NON STERILE, AQL 1.5, Class I - for general examinations and patient contact
2. Surgical gloves: STERILE, AQL 0.65, Class Is - for invasive surgical procedures
3. Chemotherapy gloves: may be required to comply with both EN 455 (medical device) and EN ISO 374 (PPE)
Materials: nitrile (standard), latex (high elasticity), vinyl (low cost), TPE/Vitril (hypoallergenic).
EN 455 compliance (Parts 1-4):
- Part 1: Leak resistance (AQL testing)
- Part 2: Physical properties (tensile strength, elongation, dimensions)
- Part 3: Biological evaluation (cytotoxicity, protein content)
- Part 4: Shelf life (ageing testing, expiry date)
Distinction: not every glove used in a medical setting is automatically a medical glove under MDR. Cleaning gloves or maintenance gloves used in hospitals are PPE, not medical devices.
Frequently asked questions
What distinguishes a medical glove from a standard protective glove?
A medical glove is tested to EN 455, carries CE as a medical device (Class I), and is specifically intended for use with patients or medical procedures. A PPE protective glove protects the wearer and is subject to EN 388, EN ISO 374, etc.
Can medical gloves also be PPE?
Yes. Chemotherapy gloves, for example, must comply with both EN 455 (medical device) and EN ISO 374 (PPE Category III), as they protect the patient from the user (medical device) and the user from chemicals (PPE).
What is the difference between an examination glove and a surgical glove?
Examination glove: NON STERILE, AQL 1.5, for general examinations. Surgical glove: STERILE, AQL 0.65, for invasive surgical procedures. Classes I and Is respectively.