National Treasure "EasyGuard Mask to Obtain US FDA ASTM LEVEL3 Certification"

[Asia Economy Reporter Hyunseok Yoo] Kukbo, a comprehensive logistics company listed on KOSPI, announced on the 7th that the KF-94 Easyguard masks certified by the Ministry of Food and Drug Safety, produced in collaboration with EZN Korea, are expected to obtain ASTM LEVEL3 certification this month, following registration with the U.S. Food and Drug Administration (FDA) as FDA Device Class 1 and 2.

In the case of dental masks, ASTM LEVEL3 certification was completed on the 2nd, recognizing their top quality. This achievement was made possible by manufacturing masks using domestic machines rather than cheap Chinese machines, utilizing excellent domestic raw and subsidiary materials, and thorough quality control.

The Easyguard masks have already completed FDA registration and CE certification, allowing export anywhere worldwide. They are undergoing testing aimed at the highest level, 510k (pre-market notification) approval, and FDA Cleared certification for the FXX code. Preparation for N95 respirators through NIOSH certification is also underway.

A company official stated, "Currently, demand for medical dental masks is rapidly increasing in the North American region, and by obtaining ASTM LEVEL3 certification, which is rare domestically, we have gained recognition not only for the competitiveness of our medical mask products but also for their distinctiveness. Thanks to these certifications, we are currently conducting local promotion and marketing through distributors in the North American region, and we understand that several local medical institutions have shown great interest."

This content was produced with the assistance of AI translation services.