CE Certification for PPE Explained: EU 2016/425 and EN Standards

By WELL Protection Technical Team

"CE marked" is the most common claim on imported PPE — and the most misunderstood. Here is what CE actually means for coveralls and gloves, and what buyers should verify.

1. The Legal Basis: EU Regulation 2016/425

Since 2018, PPE sold in the EU must comply with Regulation (EU) 2016/425. Products are classified into Categories I, II and III by risk level:

• Category I: minimal risk (simple gloves) — self-certification.
• Category II: medium risk (most industrial gloves, Type 5/6 coveralls) — third-party testing by a Notified Body.
• Category III: severe risk (chemical suits, Type 3/4, rescue) — Notified Body testing + production surveillance.

2. The Standards Behind the Mark

• Coveralls: EN ISO 13982-1 (Type 5, dust), EN 13034 (Type 6, light splash), EN 14605 (Type 3/4, liquid jet/spray).
• Gloves: EN 388 (mechanical), EN 374 (chemical), EN 511 (cold), EN 455 (medical).
• The CE certificate should name the specific EN standard and the test results.

3. What to Check on a CE Certificate

• Is the Notified Body number listed (e.g. NB 0123)?
• Does the certificate cover the exact product type and standard?
• Is there a Declaration of Conformity (DoC) from the manufacturer?
• Does the product label show the standard, protection level and manufacturer?

4. Common Red Flags

• "CE" printed without a Notified Body number on Category III products.
• Certificates that list standards the product doesn't actually meet.
• Sample passed, bulk not — always ask for batch-level test reports.

5. WELL Protection's Position

WELL Protection manufactures coveralls under EN Type 3/4/5/6 and gloves under EN 388/374, with third-party test reports and documents available for EU-bound orders. Contact: zhimin.wang@well-protection.com / WhatsApp: +86 18217712651.

Related Reading

• How to Choose a Coverall Supplier in China ([WELL Lab] How to Choose a Disposable Coverall Supplier in China: 8-Point Checklist-企业官网)
• Disposable vs Reusable Coveralls (add link)