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EN 374 vs EN 455: Which European Standard Do You Need?

Fujian Jixiang E-commerce Co., Ltd

EN 374 vs EN 455: Which European Standard Do You Need?

EN 374 vs EN 455: The Core Difference (Direct Answer)

EN 374 governs chemical and micro-organism protection for protective gloves, while EN 455 governs the quality and safety of medical gloves for single use. In short: if your priority is chemical resistance → look for EN 374. If your priority is patient/healthcare safety → look for EN 455. Many industrial buyers need both, but they serve fundamentally different purposes.

• EN 374 = "Can this glove protect me from chemicals and micro-organisms?"

• EN 455 = "Is this glove safe and reliable for medical examination/surgery?"

Comparison infographic showing EN 374 chemical and microorganism protection standards versus EN 455 medical glove safety standards, featuring a blue nitrile glove, industrial laboratory environment, and healthcare setting.

Quick Comparison Table

DimensionEN 374EN 455

| Full Title | Protective gloves against dangerous chemicals and micro-organisms | Medical gloves for single use |

| Scope | Industrial, laboratory, chemical handling | Healthcare, medical examination, surgery |

| Key Tests | Chemical permeation, degradation, penetration | Freedom from holes (AQL), physical properties, biological safety |

| Parts | EN 374-1 to EN 374-5 | EN 455-1 to EN 455-4 |

| AQL Requirement | AQL 2.5 (typically) | AQL 1.5 (examination) / AQL 0.65 (surgical) |

| PPE Category | Category III (complex design) | Medical Device (MDR 2017/745) |

| CE Marking | Yes (EU 2016/425) | Yes (MDR 2017/745) |

| Typical Users | Chemical workers, lab technicians, mechanics | Doctors, nurses, dentists, surgeons |

EN 374: Deep Dive

EN 374 is a series of standards under the PPE Regulation (EU) 2016/425. It applies to protective gloves designed to shield the wearer from hazardous chemicals and micro-organisms.

Parts of EN 374

PartWhat It TestsKey Requirement

| EN 374-1 | Terminology and performance requirements | Defines Type A, B, C based on chemical resistance |

| EN 374-2 | Resistance to penetration by micro-organisms | Water/air leak test (AQL 2.5 minimum) |

| EN 374-4 | Resistance to degradation by chemicals | Measures change in puncture resistance after chemical exposure |

| EN 374-5 | Protection against micro-organisms (viruses, bacteria, fungi) | Additional virus penetration test (ISO 16604) |

EN 374 Chemical Type Classification

TypeMin Chemicals ResistedBreakthrough TimeMarking

| Type A | 6 chemicals (from list of 18) | >= 30 min each | EN 374:2016/Type A + chemical codes |

| Type B | 3 chemicals | >= 30 min each | EN 374:2016/Type B + chemical codes |

| Type C | 1 chemical | >= 10 min | EN 374:2016/Type C + chemical code |

EN 455: Deep Dive

EN 455 is a series of standards under the Medical Device Regulation (MDR) 2017/745. It applies to gloves intended for medical use — examination, diagnosis, and therapeutic procedures.

Parts of EN 455

PartWhat It TestsKey Requirement

| EN 455-1 | Freedom from holes (pinhole defects) | AQL 1.5 (examination) / AQL 0.65 (surgical) |

| EN 455-2 | Physical properties | Tensile strength >= 14 MPa (nitrile); elongation >= 500% (nitrile) |

| EN 455-3 | Biological evaluation | Latex protein limits, endotoxin limits, powder residue limits |

| EN 455-4 | Shelf-life determination | Accelerated aging test; must maintain properties for stated shelf life |

When Do You Need Both Standards?

Some products must comply with both EN 374 and EN 455 simultaneously. This is common for:

• Chemotherapy gloves — Must meet EN 455 for medical use AND EN 374 for cytotoxic drug permeation

• Laboratory medical gloves — Used in clinical labs where both patient contact and chemical exposure occur

• Emergency response gloves — Where healthcare workers may encounter unknown substances

How to identify dual-certified gloves: Look for both markings on the packaging: "EN 455" + "EN 374" with chemical codes and CE mark.

Infographic comparing EN 374 PPE regulations and EN 455 medical device requirements, including EU legislation, intended use, notified body certification, declaration of conformity, and post-market compliance obligations for disposable gloves.

Which Standard Should You Look For?

  1. Are you using gloves for medical examination or surgery? → EN 455 is mandatory

  2. Are you handling chemicals in an industrial or lab setting? → EN 374 is required

  3. Are you a dental professional? → EN 455 (medical) + optionally EN 374 if handling chemical disinfectants

  4. Are you in food processing? → Neither is mandatory; look for EU 10/2011 or FDA 21 CFR 177 for food contact compliance

  5. Are you importing to the GCC? → GSO 4872 aligns with both EN 455 and EN 374 principles

FAQ

Q: Can a glove be both EN 374 and EN 455 certified?

A: Yes. Many high-quality nitrile gloves carry both certifications. These are typically used in clinical laboratory settings or for chemotherapy drug handling. The glove must pass the AQL 1.5 pinhole test (EN 455-1) AND the chemical permeation test (EN 374-1) to carry both marks.

Q: Is EN 455 mandatory for all gloves sold in Europe?

A: No. EN 455 is mandatory only for gloves marketed as "medical gloves." Industrial, food-handling, and general-purpose gloves do not require EN 455. However, they may need EN 374 if they claim chemical protection.

Q: What's the difference between EN 374-2 and EN 455-1 water leak tests?

A: Both tests check for pinholes, but the acceptance criteria differ. EN 455-1 requires AQL 1.5 (medical grade), while EN 374-2 typically requires AQL 2.5 (industrial grade). The test method is similar — filling the glove with water and checking for leaks.

Q: Do I need EN 374 for gloves used with cleaning products?

A: If the cleaning products contain hazardous chemicals (as defined by CLP Regulation), then yes — the employer must provide EN 374-certified gloves as PPE. For domestic cleaning with mild detergents, non-certified gloves may be sufficient, but certified gloves are always safer.

About JIXIANG: JIXIANG nitrile gloves are certified to EN 455-1/2/3/4 (medical grade, AQL 1.5) and EN 374 (chemical protection, Type B). Our ISO 13485-certified production ensures consistent quality for healthcare, laboratory, and industrial applications.

Visit www.jxgloves.com/contact for certifications and samples.

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