Scutagli, LLC

Scutagli, LLC specializes in basic male condoms made from Hevea latex. These products are designed primarily for contraception and sexually transmitted infection prevention, marketed under the name Premium Rubber Helmet Condoms. The company focuses exclusively on latex-based condoms, ensuring compliance with relevant U.S. medical device standards.

Scutagli, LLC is based in the United States. While the company’s operations and regulatory focus are centered in the U.S., its products may be distributed globally depending on market demand and compliance requirements. The company adheres to U.S. medical device regulations, including those governing latex-based condoms.

Scutagli, LLC’s male condoms fall under Class II classification by the FDA. This classification is assigned based on the device’s risk level and intended use—latex condoms are considered moderate-risk due to their role in preventing pregnancy and STIs, requiring special controls beyond general controls but not as stringent as Class III. The classification ensures compliance with performance standards and manufacturing practices.

Yes, Scutagli, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device to improve tracking, transparency, and post-market surveillance. This listing helps healthcare providers, regulators, and distributors verify the device’s identity and compliance status.

The FDA classifies condoms as Class II because they are not low-risk enough for General Controls alone (which would classify them as Class I). Instead, they require Special Controls, such as performance standards for breakage resistance, lubricant safety, and effectiveness in preventing pregnancy and STIs. This classification balances regulatory oversight with the device’s intended use, ensuring reliability without the stricter scrutiny of Class III.