Gill™ Mask earns CE Medical Device Class I MDD registration in Europe for its Gill™ Mask and Gill™ Filter
Gill™ Mask Reusable Respirator
Gill™ Mask Pro Reusable Respirator
Singapore – May 10th, 2021 –
Gill Lab, a Singapore based PPE manufacturer, announced today it has received Class I Medical Device CE Mark registration for its products – Gill™ Mask, Gill™ Mask Pro, Gill™ Filter, and Gill™ Filter Pro.
The CE Mark registration confirms that Gill™ Mask/ Gill™ Mask Pro and Gill™ Filter/ Gill™ Filter Pro meet all the provisions of the EU Medical Devices Directive Council 93/42/EEC, Annex V11. The directive outlines the safety and performance requirements for the medical device to be sold freely in the European Union.
The CE mark registration is a key milestone for Gill Lab, a fast growing and innovative company which designed their first reusable respirator, Gill™ Mask, during the onset of the Covid-19 pandemic in early 2020. Originally designed and manufactured for frontline workers in high-risk environments, Gill™ Mask provides comfortable, sustainable and cost-effective protection for anyone seeking a solution against airborne contaminants. The innovative patented adaptable cartridge design is first of its kind and ensures a high-protection comfort fit with long-lasting durability and less maintenance.
Already a notified medical device Class A with the Health Sciences Authority (HSA) of Singapore, Gill Lab has distribution warehouses in North America, Europe, and Asia. Gill Lab is planning to enter the European market with distributors and through various e-commerce platforms, such as Amazon Europe and its own website.
“Over the last year, we have seen an increasing demand in sustainable and protective equipment among the professionals. We had spent a substantial number of resources preparing for our EU entry, putting together a robust quality system in place and going through stringent testing to ensure that our products are meeting the European Medical Directives requirement,” commented Veronica Chew, CEO and Head of Commercial of Gill Lab.
Gill Lab also announced the launch of Gill™ Mask Pro and Gill™ Filter Pro, a reusable respirator with higher breathability designed for professionals who are required to wear protective equipment for extended period of time. Designed with the same biocompatible silicone face piece as the original Gill™ Mask, Gill™ Mask Pro features a wave-shaped filter cartridge system that has more than 2.5 times surface area than the current version. An upgrade kit will be made available in July 2021 to retrofit the original Gill™ Mask with the new Gill™ Mask Pro.
“I was fortunate enough to beta-test this new version of the Gill™ Mask, Gill™ Mask Pro, and I can attest to the ground-breaking breathability factor for this new design. I have no reservations wearing the Pro version for any of my longer surgical procedures and do not tire from the lack of respiration through the improved flow filter. Now all my staff and patients can clearly hear me talk and at my normal volume as well. And to add for a seasonal allergy sufferer like myself, this added airflow if greatly appreciated,” commented Dr. Viet Nguyen, Owner and Clinical Administrator of The Airport Dental Centre in Ontario, Canada.
3M Fit Testing of Gill™ Mask
Gill Lab offers two types of filter, Surgical Level II (Bacteria Filtration Efficiency (BFE) over 98% and N95 equivalent (Particulate Filtration Efficiency (PFE) over 95%).
Gill™ Mask Pro and Gill™ Filter Pro are ready for pre-order on www.gillmask.com and it is ready for shipment in June 2021. Gill™ products can also be purchased on Amazon US (www.amazon.com/shops/gilllab) and Singapore ((www.amazon.sg/shops/gill) and through authorized distributor (https://www.gillmask.com/pages/authorized-distributors).
About Gill Lab and Gill Products
Gill™ Mask and Gill™ Mask Pro reusable respirator and Gill™ Filter and Gill™ Filter Pro are intended to protect healthcare professionals and patients, as well as other wearers, by reducing the spread of airborne contaminants. Gill products are designed and manufactured by Gill Lab Pte Ltd, a medical device manufacturer that holds the ISO 13485: 2016 and EN ISO 13485: 2016 quality management system certificate (MD 739211), issued by the notifying body BSI group (2797).
For list of certificates and qualifications, please refer to Gill™ Mask’s website – https://www.gillmask.com
EU Authorized Representative
MedNet EC-REP GmbH
Borktrasse 10, 48164, Munster, Germany.
For further information or media inquiries, please contact:
+65 6899 2313