R & A Logistics Inc

R & A Logistics Inc specializes in basic male condoms made from Hevea latex. These include standard varieties as well as flavoured (e.g., banana, chocolate, ice cream), ribbed, ultrathin, and textured designs. The focus is on condoms tailored for sensory experiences, such as enhanced pleasure or sensitivity, while maintaining their primary function as a barrier contraceptive.

R & A Logistics Inc is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification and listing requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, demonstrating adherence to U.S. regulatory standards for medical devices.

The condoms produced by R & A Logistics Inc are classified as Class II medical devices under FDA regulations. This classification is based on their intended use as barrier contraceptives, which requires special controls to ensure safety and effectiveness beyond general controls. Class II devices undergo additional scrutiny to mitigate potential risks.

Yes, R & A Logistics Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for transparency and traceability in the medical device supply chain. Listing ensures that each device can be uniquely identified, tracked, and recalled if necessary, supporting patient safety and regulatory oversight.

The descriptors like ‘Intensity’ or ‘Xtra Pleasure’ refer to product features designed to enhance sensory experiences, such as texture or thickness variations. While these terms highlight consumer-focused attributes, the primary function of the condoms remains as a Class II medical device for contraception and protection against sexually transmitted infections. The design choices are intended to improve user satisfaction without altering the core regulatory classification.