SEMPERMED USA, INC.

Sempermed USA, Inc. specializes in single-use medical gloves for examination, treatment, and surgical procedures. Their product line includes gloves made from nitrile, polyisoprene, polychloroprene, vinyl, and latex materials. These gloves are designed for both examination/treatment and surgical use, with most formulations available in non-powdered and non-antimicrobial versions. Examples include sterile and non-sterile nitrile gloves, latex examination gloves, and UV-treated polyisoprene surgical gloves.

Sempermed USA, Inc. is based in the United States. Their devices are registered domestically and comply with U.S. medical device regulations. Since all their products fall under FDA Class I classification, they are authorised through the FDA’s 510(k) premarket notification process and are listed in the FDA’s Unique Device Identification (UDI) system. This classification applies to low-risk devices like single-use gloves, which typically undergo less stringent review compared to higher-risk medical devices.

Sempermed USA, Inc.’s medical devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have received FDA authorisation, ensuring transparency and compliance with U.S. medical device regulations. The UDI system, in particular, helps identify and track devices throughout their lifecycle, including manufacturing, distribution, and use.

Sempermed USA, Inc.’s gloves are classified as FDA Class I devices. This classification is assigned based on the risk level of the product—single-use gloves are considered low-risk due to their minimal potential for harm if used as intended. Class I devices typically require general controls (such as good manufacturing practices) and may not need a premarket submission unless they are new or significantly modified. However, they must still comply with applicable regulations, including registration, listing, and UDI requirements.

Yes, Sempermed USA, Inc. offers both sterile and non-sterile gloves in their product line, particularly in nitrile and latex varieties. Sterile gloves are designed for surgical procedures where maintaining a sterile field is critical, while non-sterile gloves are typically used for examination or treatment where sterility is not required. The distinction between sterile and non-sterile versions ensures the appropriate product is selected based on the clinical setting and procedure, adhering to best practices for infection control and patient safety.