National Treasure, EasyGuard Mask Obtains European CE Certification

Children's Dental Masks Also Obtain ASTM LEVEL3 Certification

[Asia Economy Reporter Jang Hyowon] Comprehensive logistics company and KOSPI-listed firm Kukbo (CEO Ha Hyun) announced on the 3rd that the KF94 Easy Guard masks, produced in collaboration with EZN Korea and certified by the Ministry of Food and Drug Safety, have obtained the European CE (CoC) certification.

The CE certification received by Kukbo this time is under the EN149 (PPE) standard with an FFP2 rating, meaning it has a fine particle (0.3㎛) filtering efficiency of 94%, which is similar in performance to the typical KF94 mask.

Kukbo’s Easy Guard KF94 mask has already acquired the ASTM LEVEL3 rating, which requires a fine particle (0.1㎛) filtering efficiency of over 98%.

With this CE certification (CoC) acquisition, Kukbo, which has been striving to differentiate its mask exports, has become the first in Korea to simultaneously hold both the European CE certification and the U.S. FDA ASTM LEVEL3 rating. This achievement lays the groundwork to target general and medical institution markets worldwide, including North America and Europe.

Building on this, Kukbo’s subsidiary, Vog International, is expected to play a pioneering role in exporting masks to Europe in cooperation with Vogner, its German headquarters. Vogner is a German brand with over 80 years of history, dealing in ski wear, golf wear, and boasting premium materials and quality. Kukbo plans to establish strategies through collaboration with Vogner headquarters to supply masks timely to places in need such as Germany, Italy, and the United Kingdom, and will begin discussions to supply CE FFP2 grade masks.

Additionally, Kukbo has demonstrated its commitment to the children’s mask market by obtaining the ASTM LEVEL3 rating for children’s dental masks. Since demand for children’s masks is difficult to predict, mask manufacturers have been reluctant to invest, leading to a global supply shortage. Kukbo views this as a good opportunity to secure competitiveness in the mask market.

ASTM refers to the performance tests required by the FDA, which is the U.S. medical mask inspection standard. It demands five test criteria: BFE (Bacterial Filtration Efficiency), PFE (Particle Filtration Efficiency), SBP (Synthetic Blood Penetration), DPT (Differential Pressure for breathability), and FTS (Flammability). It also requires passing international standards for skin sensitivity and cytotoxicity tests, making the criteria very stringent. LEVEL3 is the highest grade among ASTM levels, and Kukbo is the first domestic company to hold LEVEL3 ratings for KF94, adult dental, and children’s dental masks.

Furthermore, Kukbo’s Easy Guard masks are currently undergoing FDA 510k (pre-market notification) procedures, the final step for FDA clearance, for both KF94 and dental masks, with completion expected within this month.

A company official stated, “Until now, no domestic mask company has completed the final FDA certification after registering the FXX (Surgical) product code. Once Kukbo completes the 510k process, it will become the first company in Korea to obtain the final FDA certification (Cleared).”

Meanwhile, Kukbo is proceeding with CE certification under the EN14683 (Surgical) standard for adult and children’s dental masks, expected to be completed by March. It is also preparing for NIOSH certification for KF94 masks. Kukbo is known to be finalizing all overseas mask certifications by March, preparing export strategies for all mask categories from multiple angles.

Ha Hyun, CEO of Kukbo, stated, “We will accelerate exports based on this CE certification and strengthen sustainable business from a long-term perspective through continuous performance and quality development. We aim to overcome the current off-season mask market and emerge as a leading company in domestic mask exports.”