Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. specializes in antimicrobial surgical and medical face masks intended for single-use applications. Additionally, they produce sterilization pouches and rolls for medical instruments, as well as sterilization process indicators designed for both steam and vaporized hydrogen peroxide sterilization methods, such as the 4012 and 4211 series.

The company is based in the United States. While the name includes 'Shenzhen,' the operational headquarters and regulatory submissions are aligned with U.S. regulatory frameworks.

The devices produced by the company are classified as Class II under regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as antimicrobial masks and sterilization indicators.

The company’s devices are listed in the FDA 510(k) premarket notification database and the FDA Unique Device Identifier (UDI) system. These registries track submissions and compliance for medical devices authorized in the U.S., ensuring transparency in their regulatory status.

Sterilization process indicators, such as the 4012 (steam) and 4211 (vaporized hydrogen peroxide) series, are critical for verifying that medical instruments have undergone proper sterilization. They provide visual or chemical confirmation that the sterilization cycle was completed successfully, reducing the risk of contamination and ensuring patient safety in healthcare settings.