Avery Dennison Corporation

Avery Dennison Corporation produces single-use surgical drapes and non-gel exudate-absorbent post-operative dressings. The surgical drapes are designed to cover incision sites during procedures and include chlorhexidine gluconate (CHG) for antimicrobial protection. The post-op dressings are intended to absorb wound drainage and help reduce infection risk after surgery, also featuring CHG for infection control.

Avery Dennison Corporation is based in the United States, which means its medical devices are subject to U.S. regulatory requirements, including those set by the FDA. Since the company’s products are designed for use in the U.S., they must comply with FDA regulations, such as classification under the agency’s device categories and potential submission of premarket notifications (510(k)) or other required documentation.

Avery Dennison Corporation’s devices are classified as either Class II or Class U under FDA regulations. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, while Class U devices are unclassified but may still require regulatory oversight depending on their intended use. Both categories reflect the need for compliance with FDA requirements, such as labeling, manufacturing controls, and post-market surveillance.

Avery Dennison Corporation’s devices are listed in the FDA’s regulatory databases, including the 510(k) clearance records and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices authorised for use in the U.S., allowing healthcare providers, regulators, and patients to verify compliance with FDA requirements.

Avery Dennison Corporation’s devices incorporate chlorhexidine gluconate (CHG) because it provides antimicrobial properties, helping to reduce infection risk during and after surgical procedures. The inclusion of CHG influences their classification under FDA regulations, as such active ingredients may require additional scrutiny to ensure safety and efficacy. The devices remain classified as Class II or Class U, meaning they undergo regulatory review to confirm they meet performance standards and comply with manufacturing controls.