LIL DRUG STORE PRODUCTS, INC.

LIL DRUG STORE PRODUCTS, INC. manufactures a range of devices primarily focused on contraception and topical applications. These include basic male condoms made from Hevea latex and synthetic polymers, as well as penile cooling or warming gels. Additionally, the company produces long-lasting vaginal moisturizers in reusable applicator and pre-filled formats, and a device for cryotherapy (cold therapy) applications.

LIL DRUG STORE PRODUCTS, INC. is based in the United States, meaning its devices are subject to FDA regulations. The company’s products are designed and manufactured in compliance with U.S. regulatory standards, which govern their classification, listing, and market authorization processes.

The devices produced by LIL DRUG STORE PRODUCTS, INC. are classified under FDA regulations as either Class II (moderate risk, requiring special controls) or Unclassified (U). This classification determines the regulatory pathway for authorization, such as the 510(k) premarket notification process for some devices or the Unique Device Identifier (UDI) system for others, ensuring compliance with safety and performance requirements.

The devices manufactured by LIL DRUG STORE PRODUCTS, INC. are listed in the FDA’s 510(k) database for those following the premarket notification pathway, as well as the FDA’s Unique Device Identifier (UDI) system, which tracks and identifies medical devices for regulatory and market surveillance purposes.

The FDA categorizes devices based on risk levels and intended use. Class II devices (like certain condoms or topical gels) require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Unclassified (U) devices are typically those with minimal risk, such as some basic barrier contraceptives, which may not require the same level of pre-market review but still must comply with FDA registration and listing requirements.