Surgical masks

Irema’s surgical masks, produced under the Facemate brand, and are made to Medical Device Regulation MDR EU 2017/745, which all medical masks sold in Europe must conform to since May 2021. We can also produce the same, standards compliant masks under your brand.

We provide a regular supply of Irema Facemate surgical masks to distributors all over Europe.

If it doesn’t say Irema on the box – it might be Irema in the box! Our OEM branded products also meet the same CE, regulatory and industry standards.

Irema is known for reliability and our quality and service is second to none. Our doctor, nurses and techician end users love our masks because they are comfortable and are easy to breath through.

Irema’s EU compliant medical masks ensure that healthcare workers are protected from even the smallest airborne contaminants.

  • EU and international standards ISO16890, EN 779 and MDR
  • Regular, guaranteed supply to medical distributors and OEMs worldwide
  • Breathable, comfortable surgical masks that protect

Facemate and privately labelled masks are compliant with Surgical Mask Standards EN 14684:2019

We provide a regular supply of Irema Facemate medical masks to distributors all over Europe

Surgical masks

Our disposable standard medical and surgical Facemate face masks meet the highest industry standards for Bacterial Filtration Efficiency BFE (> 98%). Our 3-ply and 4-ply, latex free, hypoallergenic, surgical face masks are available in a range of colours.

We produce 3 groups of face masks: tie-on surgical, earloop surgical and respirator.




XtraComfort for sensitive skin


  • Blue, green and white
  • Type II
  • Type IIR





Extra large

  • Blue, green and white
  • Type II
  • Type IIR (Anti-splash)

Partner with Irema – private label

Leave the manufacturing to the experts while you concentrate on core business. Outsource and partner with Irema. Your branded face masks will be produced on a dedicated production line. Create brand awareness and recognition with high quality, standards-compliant face masks packaged to your brand specification.

Trusted manufacturer to leading worldwide medical device suppliers

Irema manufactures and produces all products in line with MDR EU 2017/745 and other EU and international regulations.