F & L Medical Products Co.

F & L Medical Products Co. specializes in surgical gloves and radiation shielding solutions. Their primary products include non-powdered polychloroprene surgical gloves, as well as radiation-shielding gloves (for procedure preparation), mittens, portable panels, aprons, and collars. These items are designed to protect medical personnel during surgical and diagnostic procedures, particularly where radiation exposure is a concern.

F & L Medical Products Co. is based in the United States, meaning their devices are subject to U.S. regulatory standards, including those set by the FDA. This includes compliance with FDA requirements for classification, registration, and reporting—such as listing in the FDA’s 510(k) and UDI databases. Their U.S. location also ensures alignment with domestic manufacturing and quality control guidelines.

F & L Medical Products Co.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) pathway is used for devices deemed substantially equivalent to predicate devices, while the UDI system ensures unique identification for traceability, safety, and regulatory tracking. Both registries are critical for transparency in the medical device supply chain and compliance with U.S. regulations.

All of F & L Medical Products Co.’s devices fall under FDA Class I classification. This classification applies to low-risk devices that pose minimal potential harm to users, such as surgical gloves and radiation shielding accessories. Class I devices typically require general controls (like registration, labeling, and manufacturing practices) rather than stringent pre-market approval, reflecting their lower risk profile.