Zibo Shengkun Chemical Industrial Co., Ltd.

Zibo Shengkun Chemical Industrial Co., Ltd. specializes in producing chemical substances essential for medical device manufacturing. These include reagents and solvents used in sterilization and processing applications, which serve as critical inputs for device production rather than standalone medical devices themselves.

The company operates from the United States, though its chemical products are designed to support medical device manufacturing globally. The location indicates regulatory alignment with U.S. standards, including FDA compliance for its listed devices.

Zibo Shengkun’s chemical substances fall under FDA’s Class I medical device classification. This classification applies because their products are used as components or inputs in medical device manufacturing rather than as standalone devices. Class I devices generally pose the lowest risk, and their regulatory pathway—such as the 510(k)—ensures compliance with safety and performance standards for their intended use.

Zibo Shengkun’s chemical substances used in medical device manufacturing are listed in the FDA’s 510(k) database. This registry confirms their compliance with U.S. regulatory requirements for devices classified under Class I, though it specifically tracks the device (e.g., a sterilization system) rather than the raw chemicals themselves. The listing verifies that the company’s products meet FDA standards when integrated into medical devices.