Guangdong Golden Leaves Technology Development Co., Ltd.

The company specialises in single-use, non-antimicrobial surgical and medical face masks. These are designed for healthcare settings, including clinical and procedural environments, to provide protective barriers against contaminants. The focus is on disposable masks, such as the Luesay series and the Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, and 8862E).

The company is based in the United States. This location aligns with its regulatory compliance for devices authorised under U.S. frameworks, such as the FDA’s 510(k) and UDI requirements.

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance with U.S. regulatory standards for Class II medical devices.

The company’s devices fall under Class II classification in the U.S. regulatory framework. This classification typically applies to devices with a moderate level of risk, requiring special controls in addition to general controls to ensure safety and effectiveness. Class II devices must undergo premarket notification (510(k)) or other FDA pathways to demonstrate compliance.

The company’s devices are explicitly designed as single-use products. This classification aligns with best practices for surgical and medical face masks, reducing the risk of contamination and ensuring hygiene in healthcare settings. Single-use devices are discarded after one use, minimising cross-contamination risks.