Total Source Manufacturing

Total Source Manufacturing specializes in Hevea-latex examination gloves, specifically non-powdered and non-antimicrobial varieties. Their primary focus is on single-use exam gloves designed for medical and treatment purposes, including powder-free latex gloves with enhanced grip textures (like SureGrip and Technigrip) and nitrile exam gloves as an alternative. These devices are intended for clinical settings to minimize contamination and latex-related risks.

Total Source Manufacturing is based in the United States. Their devices are developed and distributed within the U.S. market, adhering to applicable U.S. medical device regulations. The company’s products are tailored to meet the needs of healthcare providers in clinical environments.

Total Source Manufacturing’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized medical devices in the U.S., including their Class I examination gloves. Listing in the UDI database is a requirement for certain medical devices to facilitate tracking and compliance.

Total Source Manufacturing’s devices fall under Class I classification according to FDA regulations. This classification applies to low-risk medical devices like non-powdered, non-antimicrobial latex exam gloves, which generally pose minimal risk to patients and users. Class I devices typically require less stringent regulatory oversight but must still meet performance and safety standards.