Why Certifications Matter
When importing PPE products, understanding certification requirements is crucial. Different markets have different regulatory frameworks, and non-compliant products can lead to customs delays, fines, or even legal liability.
Key Certifications Explained
CE Marking (European Union)
The CE mark indicates that a product meets EU health, safety, and environmental protection standards. For PPE:
- Category I — minimal risk (e.g., gardening gloves)
- Category II — intermediate risk (e.g., industrial gloves)
- Category III — high risk (e.g., medical surgical gloves)
A Notified Body must verify Category III PPE before CE marking can be applied.
FDA Registration (United States)
For medical-grade PPE sold in the US:
- Medical devices (including exam gloves) must be registered with the FDA
- 510(k) clearance may be required for certain device classifications
- Facility registration and device listing are mandatory
ISO 13485
This international standard specifies requirements for quality management systems in the medical device industry:
- Covers design, development, production, and delivery
- Required by many countries as a prerequisite for market access
- Demonstrates consistent quality and regulatory compliance
EN 455 (Medical Gloves)
The European standard for medical gloves covers four parts:
- EN 455-1 — Freedom from holes (AQL testing)
- EN 455-2 — Physical properties (tensile strength, dimensions)
- EN 455-3 — Biological evaluation (biocompatibility)
- EN 455-4 — Shelf life determination
EN 14683 (Medical Face Masks)
Specifies requirements for medical face masks:
- Type I — Bacterial Filtration Efficiency (BFE) ≥ 95%
- Type II — BFE ≥ 98%
- Type IIR — BFE ≥ 98% + splash resistant
GB 2626 / EN 149 (Respirators)
- KN95 (Chinese standard GB 2626) — ≥ 95% filtration
- FFP2 (European standard EN 149) — ≥ 94% filtration
- Both provide high-level respiratory protection
Market-Specific Requirements
| Market | Key Requirements |
| --- | --- |
| EU | CE marking, EU Declaration of Conformity |
| USA | FDA registration, 510(k) if applicable |
| Canada | MDEL license from Health Canada |
| Australia | TGA registration |
| Middle East | Gulf Conformity mark (G mark) in some countries |
How SAFEWELL Can Help
Our team has deep experience navigating international PPE regulations. We provide complete documentation packages including certificates, test reports, and declarations of conformity for all target markets.