DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO., LTD.

DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO., LTD. specializes in single-use, non-antimicrobial surgical and medical respirators. These devices are intended for clinical environments and are designed to meet specific patient care needs. The focus is on disposable respiratory protection, ensuring hygiene and safety in medical settings.

The company is based in the United States. This location allows it to align with regulatory requirements and market demands specific to the US healthcare system, ensuring compliance with local standards for medical devices.

The devices produced by DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO., LTD. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, safety, and quality purposes, ensuring transparency in the supply chain.

The company’s devices, specifically single-use surgical and medical respirators, are classified as Class II under regulatory frameworks. This classification typically indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness, such as performance standards and post-market surveillance.

Yes, some of the respirators produced by DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO., LTD. are distributed under the Makrite Industries Inc. brand. This branding helps differentiate the product line while maintaining consistency in quality and regulatory compliance for clinical use.