Delivering Good Health and Reliability

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Feb. 22 , 2019

New type of surgical masks – first in Japan! (*1)
Cufitec® Surgical Masks from NBC Meshtec were cleared by the U.S.
Food and Drug Administration (FDA) as a medical device
under the name “Surgical Mask with Antimicrobial/Antiviral Agent”.
On January 3 (Thursday), 2019, Cufitec® Surgical Masks that are manufactured and sold by
Nisshin Seifun Group company NBC Meshtec Inc. (president: Akiya Fukada) were cleared as

medical devices by the U.S. Food and Drug Administration (FDA), classified as a Surgical Maskwith Antimicrobial/Antiviral Agent (class 2,510 (k)). NBC Meshtec is the first Japanese company
to obtain this clearance(*1) As of January 3, 2019. Investigation by our company.

■ Cufitec® Surgical Masks: Overview of antimicrobial/antiviral surgical masks
The Cufitec® Surgical Masks (*2) from NBC Meshtec were developed in order to reduce the riskof infection caused by the spread of viruses adhering to the mask surface when the mask isremoved and disposed of.
Cufitec® Surgical Masks are composed of 4 layers of non-woven fabric, with anantimicrobial/antiviral treatment applied to the outer and face side layers (Figure 1). It has been
confirmed that this antimicrobial/antiviral non-woven fabric functions to inactivate 99.99% ormore of influenza viruses of various types within 5 minutes.
In addition, because it was also confirmed that these masks satisfy the FDA standards forsafety and medical mask performance, they were cleared as FDA medical devices (class 2,510(k)).
(*2) Cufitec® is an virus and bacteria control technology utilizing
nano-particles of a monovalent copper compound.

Figure 1: Structure of Cufitec® Surgical Masks* This product is not a medical device intended for the treatment or prevention ofillnesses in Japan.

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Table 1: Virus strains used in the performance tests
Virus type
A/H1N1

Virus strain name
A/Virginia/ATCC2/2009
A/WS/33

A/H3N2

A/Kitakyusyu/159/93
A/Victoria/210/09
A/Virginia/ATCC6/2012
A/Hong Kong/8/68
A/Udorn/307/72

B

B/Lee/40
B/Taiwan/2/62■ “510 (k)” clearance
In order to sell a medical device in the United States, it is necessary to satisfy the standards
established by the FDA. Because an antimicrobial/anti-viral surgical mask is classified as aClass 2 medical device, 510 (k) clearance is necessary. Cufitec® Surgical Masks passed the tests(*3) required for this clearance and was cleared by the FDA as a medical device (510 (k) number:K182766).
(*3) Tests required for 510 (k) certification
In order to obtain clearance, in addition to satisfying the basic required anti-virus
performance of deactivating 99.99% of viruses within 5 minutes, it is necessary to prove that thisbasic performance can be maintained even when affected by repeated virus exposure, contact
with user saliva, breathing, and other factors. Test results from a minimum of 3 lots are
required.
In order to verify safety, in addition to basic safety tests such as the cytotoxicity test, primaryskin irritation test, and skin sensitization test, it is also necessary to conduct chemical safety
tests to ensure safety in the unlikely event that the antimicrobial/anti-viral agent somehow
becomes separated or elutes from the mask.
The bacterial filtration efficiency, particulate filtration efficiency, synthetic blood penetration
resistance, differential pressure, flammability, and other performance standards required ofsurgical masks must also be satisfied.

■ Future plans
NBC Meshtec intends to expand sales of FDA-cleared Cufitec® Surgical Masks andantimicrobial/anti-viral non-woven fabrics in Japan and overseas, and also to utilize thecompany’s original “Cufitec®” virus and bacteria control technology in order to further createclean, safe, and comfortable environments.

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Please direct any inquiries regarding the product or technologies to the following.
NBC Meshtec Inc. Market Development Division
2-50-3 Toyoda, Hino-shi, Tokyo
Tel: 042-582-2496 Email: cufitec_nbc@nisshin.com

Please direct any media inquiries regarding this matter to the following.
In charge: Hiraki, Shiroishi
PR Dept., General Affairs Div., Nisshin Seifun Group Headquarters
Tel: 03-3582-6650

Email: mailbox@mail.nisshin.com

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