GROVE COLLABORATIVE, INC.

Grove Collaborative, Inc. specializes in three primary categories of medical devices: basic male condoms made from Hevea latex, unscented menstrual tampons, and sexual lubricants. The lubricants are branded as 'Sustain' and come in standard and natural (unscented) formulations, with some variants explicitly designed for use with latex condoms. These products are developed to meet specific consumer needs in personal health and hygiene.

Grove Collaborative, Inc. is based in the United States. As a U.S.-based manufacturer, the company must comply with the regulatory requirements set by the FDA for the devices it produces. Since its products fall under Class II classification, they are subject to special controls and must meet performance standards, labeling requirements, and other regulatory obligations outlined by the FDA for these categories.

Yes, Grove Collaborative’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it ensures traceability and transparency in the medical device supply chain. The UDI system helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle, reducing risks like counterfeiting, recalls, and adverse events by providing a standardized way to identify specific devices.

Grove Collaborative’s devices are classified as Class II medical devices by the FDA. This classification implies that while the products pose moderate risk, they require special controls beyond general controls (like good manufacturing practices) to ensure safety and effectiveness. Class II devices often require performance standards, labeling requirements, or post-market surveillance to mitigate potential risks, ensuring they meet the intended use without compromising patient safety.