ANGELINE GROUP LTD.

Angeline Group Ltd. specializes in surgical face masks, which are intended for use in medical and healthcare environments to help prevent the spread of infections. These devices are engineered to meet strict infection control standards, ensuring protection for both patients and healthcare providers.

Angeline Group Ltd. is headquartered in Taiwan, where it designs and manufactures its medical devices. The company’s location in Taiwan supports its operations in producing high-quality, regulated medical products.

The surgical face masks produced by Angeline Group Ltd. fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance testing and manufacturing process validation.

Angeline Group Ltd.’s surgical face masks are listed under the FDA’s 510(k) pathway, a regulatory process used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This pathway ensures compliance with U.S. regulatory requirements before market introduction.