National Treasure Obtains ASTM Level 3 Certification for Both KF94 and Dental Masks

Collaboration with Canadian Emercares
Full-scale Entry into the North American Mask Market

[Asia Economy Reporter Jang Hyowon] On the 7th, Kukbo (CEO Ha Hyun), a comprehensive logistics company listed on KOSPI, announced that the KF94 Easy Guard mask, certified by the Ministry of Food and Drug Safety and produced by the manufacturer EGEN Korea, obtained ASTM LEVEL3 certification from the U.S. Food and Drug Administration (FDA) on the 30th of last month.

With this, Kukbo became the first company in Korea to simultaneously acquire ASTM LEVEL3 certification for both KF94 masks and dental masks. This means that the masks are recognized as top-quality products suitable for use by medical institution staff and patients, and are even appropriate for surgical (OR) use.

ASTM refers to the performance tests required by the FDA for medical masks in the U.S. It demands five test criteria: BFE (Bacterial Filtration Efficiency), PFE (Particle Filtration Efficiency), SBP (Synthetic Blood Penetration), DPT (Differential Pressure Test for breathability), and FTS (Flammability Test). Additionally, masks must pass international standards for skin sensitivity and cytotoxicity tests, making the criteria very stringent.

LEVEL3 is the highest grade among ASTM levels, and in Korea, only two companies including Kukbo have obtained LEVEL3 certification for KF94 masks. Kukbo is the first in Korea to achieve LEVEL3 certification for dental masks as well.

Furthermore, the Easy Guard mask is currently undergoing FDA review after receiving the 510k (pre-market notification) number, which is the final step for FDA Cleared certification, expected to be completed by the end of this month. Until now, no mask companies in Korea have completed the full FDA certification process for the FXX (Surgical) product code, only registering the FDA product code.

A company representative emphasized, “It is common for companies to exaggerate by claiming FDA certification just by registering the FDA product code and even labeling their products as such. However, code registration only means that product information is entered into the FDA database, whereas code certification means that the FDA has recognized that the registered product meets performance and quality standards. There is a significant difference between registration and certification.”

Leveraging this certification, Kukbo is aggressively promoting and marketing by collaborating with Canada’s Emercares to secure distribution networks in North America and establishing a website for North American marketing.

In particular, to address the current shortage of N95 respirators in the North American medical field, Kukbo is preparing for NIOSH certification of its KF94 masks and is actively negotiating contracts with North American medical companies.