office of the chief executive officer james michael lafferty t ......office of the chief executive...

Office of the Chief Executive Officer James Michael Lafferty T: +971 4 8815276 P.O. Box 16927 Dubai - UAE [email protected] | www.finehh.com

To Whom it may Concern: April 15, 2020 Let me first of all thank you for your inquiry regarding Fine Guard. With such an important personal accessory, it is both common and prudent to ask questions about a mask’s performance. We can assure you Fine Guard, developed with the Livinguard Company in Switzerland, is perhaps the single-most researched and documented mask in the world. It is protected by over one dozen patents; and over 10 clinical studies have been performed by independent labs to assess its ability to neutralize pathogens. This data has been thoroughly reviewed by governments across the globe and universally accepted as sound. I do not want to overwhelm you with data, but I do want to answer your questions. So, let me give you here an amended report which I hope answers all your questions. Let me walk through this step-by-step to make it a smooth flow.

1. We in FHH (Fine Hygienic Holding) have been developing this mask and other textile and paper-based products with the scientists at Livinguard for over 2 years. Livinguard is a Swiss Company, backed by multiple investors including KKR, which has over a dozen patents on their revolutionary technology which kills all forms of pathogens—bacteria, viruses, and fungi—via a safe, “mechanical” means, instead of using poisonous chemistry. We see applications well beyond masks to gloves, wipes, and even onto our paper products at some point like Fine Tissues. A simple visual of the 4 steps of how Livinguard technology works is illustrated in the slide below:


2. For purposes of clarity, any data regarding “Livinguard” and any data referring to “Fine

Guard” are interchangeable. Fine Guard is 100% produced under supervision of Livinguard and as the below letter attests, the mask is simply co-branded but is identical in all respects to the masks used in data generation.


3. Fine Guard has been thoroughly tested by Nelson’s Laboratories in the USA for product safety. Nelson’s set the standard for mask testing worldwide, and Fine Guard has passed all tests impeccably as detailed below:

4. The filtration of our N95 filter medium is well-documented. Livinguard only sources N95 grade filter medium from approved worldwide suppliers. The N95 is a double layer in the middle of the mask—you can take the mask apart and see the two white layers of N95 filter medium inside a Fine Guard Mask. We separately ran independent third-party laboratory tests to measure the washability and filtration of our N95 materials. Please see a copy of the laboratory report below.


5. We have many independent laboratory reports on the efficacy of Livinguard treated fabrics, such as Fine Guard Masks, in the neutralization of bacteria and viruses. For brevity I am going to focus solely on anti-viral properties (as the current focus of the world is on a virus) and also focus on two separate studies, one from India and the other from the prestigious NSF in the US which is part of the University of Michigan and does all testing for US military. I have attached below the summary from BioTech Services Labs (BTS) in India which refers specifically to the effectiveness against enveloped viruses such as Coronavirus; and the summary table of germ kill against both bacteria and Viruses (Both MS2 and fr Coliphages are typical viruses used for laboratory validation) from NSF.

BTS Lab Report Excerpt: NSF Lab Report Tables:


6. All of the clinical studies were submitted to the leading wellness association in the world, the Medical Wellness Association based in Houston, Texas. A panel of 30 leading physicians reviewed all the clinical data and decided Fine Guard would be the ONLY mask recommended for infection prevention by the MWA. A copy of their certification is below.


7. We have additionally asked for TUV certification from the Dubai Government-approved

UAE laboratories, as well as we have recently submitted a self-declaration for European Union (CE) certification for both N95 and Anti-viral properties. Attached are copies of each.


8. Finally, we have obtained multiple FDA certifications from around the globe. We are on fast-track approval for US FDA, expected this week. We have just closed an order with the Government of Singapore to supply over 10 million masks to equip the entire population, after a medical panel reviewed all the clinical data. Attached as examples is a copy of the certification from the FDA of Kingdom of Saudi Arabia and approvals from the Australian Government. Of note, the Saudi FDA was impressed to the extent they decided to give Fine Guard a Medical Device classification!

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Australian Register of Therapeutic Goods CertificateIssued to

M4 Medical Pty Ltdfor approval to supply

M4 Medical Pty Ltd - Mask, surgical, reusableARTG Identifier 335554ARTG Start Date 1/05/2020Product Category Medical Device Included Class 1GMDN 37713GMDN Term Mask, surgical, reusableIntended Purpose An N95 reusable mask placed over the nose and mouth by medical

personnel to prevent the transmission of airborne organisms while surgery is being performed.

Manufacturer Details Address Certificate number(s)

FINE HYGIENIC PAPER FZE PLOT NO EWRA 56 JEBAL ALAI FREE ZONE PO BOX 16927 , DUBAI , United Arab Emirates

ARTG Standard ConditionsThe above Medical Device Included Class 1 has been entered on the Register subject to the followingconditions:· - The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or

imposed on the ARTG entry. Refer Part 4-5, Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for relevant information.- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence; and civil penalties may apply.

Products Covered by This Entry1. Mask, surgical, reusable

Product Specific ConditionsNo specific conditions have been recorded against this entry.

Therapeutic Goods Administration PO Box 100, Woden ACT 2606 Australia Phone: 1800 020 653 Email: [email protected]

ARTG Identifier: 335554 ARTG Start Date: 1/05/2020


I hope this answers all questions that you may have, and I rest at your disposal to answer any other questions. We are very proud of our mask and very happy to help the world. Whilst purely anecdotal, we are proud of the fact we gifted a mask to our 4,000 employees in February, and they all use it. Despite being spread across 20 countries and in high-risk situations/living conditions, to date we have not had one single case of COVID-19 infection among our employees! This is an amazing statistic and partially reflects, we believe, the superior protection our mask offers, beyond merely filtration, but in neutralizing pathogens as they come into contact with the mask. Thank you again. I rest at your disposal. Respectfully submitted, James Michael Lafferty Chief Executive Officer Fine Hygienic Holding

office of the chief executive officer james michael lafferty t ......office of the chief executive...

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