What Certifications Are Required for Non-woven Face Masks in the EU and US Markets?

In the global trade of medical and protective equipment, compliance is not just a formality—it is the lifeline of your business. For importers and procurement managers, navigating the labyrinth of international standards for non-woven face masks can be daunting. A single missing document or an incorrect certification can lead to seized shipments, heavy fines, and legal liabilities.

This guide provides a detailed breakdown of the mandatory certifications and standards required to successfully enter the European Union (EU) and United States (US) markets.

1. The European Union (EU) Market: The CE Marking System

In the EU, non-woven face masks are categorized into two distinct groups based on their intended use. Each follows a different regulatory path.

A. Medical Face Masks (Surgical Masks)

These are intended to protect the patient from the wearer’s exhalations and to protect the wearer from splashes of potentially contaminated liquids.

• Regulatory Framework: Medical Device Regulation (MDR) EU 2017/745.

• Technical Standard: EN 14683:2019.

• Classification:

• Type I: Bacterial Filtration Efficiency (BFE) ≥ 95%. Used for patients and others to reduce the risk of spread of infections.

• Type II: BFE ≥ 98%. Used by healthcare professionals in a hospital setting.

• Type IIR: BFE ≥ 98% + Splash Resistance. Offers the highest level of protection against fluids.

• Compliance Path: Manufacturers must prepare a Technical File, sign a Declaration of Conformity (DoC), and appoint an Authorized Representative (EC Rep) if based outside the EU.

B. Personal Protective Equipment (PPE Masks/Respirators)

These are designed to protect the wearer from particulates, dust, and aerosols (e.g., FFP2/FFP3 masks).

• Regulatory Framework: PPE Regulation (EU) 2016/425.

• Technical Standard: EN 149:2001+A1:2009.

• Classification: FFP1, FFP2, and FFP3 (based on filtration efficiency and leakage).

• Critical Requirement: Unlike Type I medical masks, PPE masks must be certified by a Notified Body (NB). The CE mark on the packaging must be followed by a 4-digit number (e.g., CE 2834) identifying the specific notified body that performed the audit.

2. The United States Market: FDA & NIOSH Oversight

The US market is governed by two primary agencies: the Food and Drug Administration (FDA) for medical use and the National Institute for Occupational Safety and Health (NIOSH) for industrial safety.

A. Surgical Masks

• Regulatory Body: FDA.

• Technical Standard: ASTM F2100.

• Classification:

• Level 1: Low risk of fluid exposure.

• Level 2: Moderate risk of fluid exposure.

• Level 3: High risk of fluid exposure (highest splash resistance).

• Requirements: Manufacturers must complete Facility Registration and Device Listing. Most surgical masks require a 510(k) premarket notification, although some exemptions were applied during the public health emergency (always check current FDA status).

B. N95 Respirators

• Regulatory Body: NIOSH (under the CDC).

• Technical Standard: 42 CFR Part 84.

• Key Feature: To be labeled as an "N95," the mask must filter at least 95% of airborne particles.

• Surgical N95: If a mask is intended for both respiratory protection and surgical splash resistance, it requires dual certification from both NIOSH and the FDA.

3. Technical Comparison at a Glance

4. How to Verify Certificate Authenticity

To protect your investment, follow these verification steps:

1. Check the NANDO Database (EU): For FFP2/3 masks, verify the 4-digit number on the NANDO website to ensure the organization is actually authorized to certify PPE.

2. FDA Establishment Search (US): Use the FDA Registration & Device Listing database to confirm the supplier’s registration status.

3. Beware of "Certificates of Compliance": Many third-party labs issue "Certificates of Compliance" that look official but have no legal standing for CE marking. Only a Declaration of Conformity (for medical) or a Module B/C2/D Certificate from a Notified Body (for PPE) is valid.

5. Why Partner With Us?

Navigating these regulations requires a manufacturer that prioritizes transparency and quality.

• Fully Certified: We hold valid ISO 13485 Quality Management certification, along with CE MDR and FDA registrations.

• Rigorous Testing: Every batch of our non-woven fabric and finished masks undergoes testing in our internal lab and is periodically verified by world-leading agencies like SGS and TUV.

• Export Expertise: We provide a complete documentation package—including test reports, DoC, and EC Rep info—to ensure your customs clearance is seamless.

Conclusion

Whether you are sourcing for a hospital network in Germany or a retail chain in the United States, understanding these standards is the first step toward a successful partnership. Don't let regulatory hurdles slow down your supply chain.

Looking for a reliable, fully compliant mask manufacturer?
Contact Our Export Team Today to request our latest test reports and certification portfolio.