The Langie comes from a long-standing trusted manufacturing relationship between Casey Kerrigan, a Harvard M.D. turned shoe manufacturer and her manufacturing partner in China, Charlie Tian, who happened to have bought a facemask factory several years ago.
Features of the Langie
Five-layer high-efficiency filtering of > 95% compared to typical three or four layers in other KN95s
Exceptional breathability that exceeds NIOSH’s standards with an inhalation resistance < 100 Pa at 85 L/min and an exhalation resistance < 100 Pa at 85 L/min
Ergonomic bi-fold 3D shape design accommodating variable face sizes and shapes to provide a better fit and seal compared to the traditional cup-shape design
A foam fitted nosepiece, not common to other KN95s, works in combination with a hidden moldable polyethylene-coated metal nosepiece to improve fit and comfort
Ultrasonic sealed elastic straps, hypoallergenic, latex-free
With the COVID-19 crisis, U.S. healthcare entities have been unable to find N95 filtering facepiece respirators (FFRs) that can be trusted not to be counterfeit or have false documentation. Equivalent KN95 respirators offer a cost-effective alternative, however many are currently being manufactured in make-shift factories with questionable raw materials, experience, tooling, and equipment. The Langie KN95 comes from an established FFR factory that makes it own raw materials and has been operating since 2014.
Available in Quantities of 50,000 to 10,000,000
While both N95s and KN95s are predominantly made in China and have the same > 95% filtration efficiency, N95s are authorized by the U.S. CDC (Center for Disease Control) by NIOSH and KN95s are authorized by the Chinese CDC (Chinese Center for Disease Control and Prevention) with GB2626-2006 certification. The Langie KN95 is recognized as providing equivalent filtration efficiency as an N95 on the basis of not only its GB2626-2006 certification in China, but also its EN149-2001 CE certification in Europe.
The Langie KN95 is awaiting authorization by the FDA for an EUA for emergency use by healthcare personnel in healthcare settings. With an FDA-EUA, the Langie KN95 filtering facepiece respirator will be authorized for use when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulate during filtering facemask shortages resulting from the COVID-19 outbreak.
 These healthcare personnel include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel.)