Level 2, Flat-Folded NordiwellTM Surgical Mask is 510K cleared
2021-07-09
News
Combat surgical mask receives FDA 510K clearance
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- Time of issue:2021-01-14 09:05
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(Summary description)
Combat surgical mask receives FDA 510K clearance
(Summary description)
- Categories:Company News
- Author:
- Origin:
- Time of issue:2021-01-14 09:05
- Views:
Information
Dec.30, 2020, Our NordiwellTM surgical mask received the U.S. Food and Drug Administration's 510(k) clearance, and it can be used in a variety of settings, such as hospitals, clinics, schools, retail, hospitality, and others.
The mask is optimized for reliable protection, exceptional breathability and comfort, and meets applicable Level 3 performance requirements for BFE, PFE, fluid resistance, differential pressure and flammability, which offers a high level of protection for medical use in environments such as operating rooms.
To date, combat has partnered with several distributors to help getting the surgical masks out to as many people as possible.
Please contact us for more information about the technical specification of the product.
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