Certifications & Quality
Our commitment to quality is backed by leading certifications and rigorous quality processes.
Our Certifications
All Hynex products comply with the strictest European requirements for safety, quality and sustainability.
CE Marking
European conformity marking indicating that products comply with EU legislation.
- Mandatory for medical devices and PPE
- All Hynex gloves and protective clothing are CE-marked
EU Regulation 2017/745 (MDR)
European regulation for medical devices (Medical Device Regulation). Sets strict requirements for clinical evidence, traceability and safety.
- Stricter requirements for clinical evidence and traceability
- Applicable to medical gloves and face masks
EU Regulation 2016/425 (PPE)
European regulation for personal protective equipment (PPE). Governs the requirements that PPE must meet before being placed on the EU market.
- Mandatory for all personal protective equipment on the EU market
- Applicable to protective gloves and clothing
ISO 9001:2015
International quality management system that guarantees consistent production and delivery processes.
- Consistent production and delivery processes
- Annual audits by independent certification bodies
FSC Certification
Forest Stewardship Council — guarantees sustainable forest management for paper products.
- Guarantees sustainable forest management
- Applicable to all Hynex hygiene paper
Download Certificates
Download the Declaration of Conformity certificates for our products.
Nitrile Gloves M3.5g (Medical Device)
Nitrile Extra Strong M5.0g (PPE)
Diamond Extra Grip M8.0g (PPE)
Our Quality Process
From raw material to finished product — every stage is inspected and documented.
Raw Material Inspection
Incoming materials are tested against specifications before being incorporated into the production process.
Production Monitoring
Continuous monitoring during the production process to immediately detect and correct deviations.
Batch Sampling
AQL tests on every produced batch ensure that only approved products are released.
Traceability
Full lot traceability from raw material to finished product for maximum transparency and safety.
Questions about our certifications?
Our team is happy to help with technical documentation, certificates or specific product requirements. Feel free to get in touch.