Welcron, CareOn Mask First Approval by US FDA

[Asia Economy Reporter Moon Hyewon] As the status of the K-quarantine brand rises globally, domestically produced masks have also contributed to preventing the spread of COVID-19 by receiving approval for use from the U.S. Food and Drug Administration (FDA).

Welcron Group announced on the 4th that Welcron Healthcare's 'CareOn Basic Mask KF94' has received approval for use from the U.S. FDA.

This approval was conducted in accordance with the U.S. Medical Device Act. The CareOn Basic Mask KF94 was classified as 'Medical Class 1' after receiving suitability certification for the Korean official test report (KF94), human toxicity, product performance, and production technology. The U.S. FDA classifies medical classes from 1 to 3 based on the impact on the human body.

The product is a yellow dust and quarantine mask using Welcron's high-efficiency melt-blown (MB) filter. It uses a four-layer filtration system and Welcron's melt-blown (MB) filter to block fine particles as small as 0.4μm. The mask material applies the 'Aquatrans' technique, which quickly absorbs and releases moisture; this patented technology was originally used in functional sportswear. It provides a fresh wearing sensation even after long hours of use and can be worn without fogging glasses.

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