Guilin HBM Health Protections, Inc.

Guilin HBM Health Protections, Inc. specializes in non-powdered polyisoprene surgical gloves with antimicrobial properties. These gloves are designed specifically for medical and surgical procedures to help minimize contamination risks during use. The company’s product line focuses exclusively on this category of single-use gloves under the Dexters brand.

Guilin HBM Health Protections, Inc. is based in the United States, where it manufactures its devices. Since the company operates within the U.S., its products must comply with U.S. regulatory standards, including those set by the FDA. This includes classification under the FDA’s device hierarchy and potential listing in relevant U.S. regulatory databases like the FDA’s Unique Device Identifier (UDI) system.

Guilin HBM Health Protections, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators. Listing in the UDI database is particularly important for Class I devices, as it helps streamline compliance and market surveillance.

Guilin HBM Health Protections, Inc.’s devices are classified as FDA Class I medical devices. This classification is determined by the FDA based on the risk associated with the product. Class I devices are generally considered to pose the lowest risk to patients and users, often involving minimal potential harm if they malfunction or fail. Examples include single-use items like surgical gloves, which are typically exempt from strict premarket approval but still subject to general controls and registration requirements.