RB Health (us) LLC

RB Health (US) LLC specializes in reproductive health devices, primarily focusing on basic male condoms made from Hevea latex and synthetic polymers. Their portfolio includes standard, flavored, and textured variants like cherry-flavored condoms, as well as penile rings and vaginal lubricants. These products are designed for contraception, barrier protection, and sexual health enhancement.

RB Health (US) LLC is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class II devices, they must comply with FDA regulations, including premarket notifications (510(k)) and Unique Device Identification (UDI) requirements. The U.S. regulatory framework ensures these products meet safety, effectiveness, and performance standards before entering the market.

RB Health (US) LLC’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions proving their devices are substantially equivalent to legally marketed predicates, while the UDI system ensures traceability and transparency in the supply chain. These listings help healthcare providers, regulators, and patients verify the device’s authorized status and compliance with U.S. regulations.

RB Health (US) LLC’s devices are classified as Class II by the FDA, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification typically involves mandatory registration, listing, and compliance with FDA-recognized standards or post-market surveillance requirements. Class II devices require premarket notification (510(k)) to demonstrate equivalence to existing approved devices.