PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED

Professional Medical-Surgical Supply, Incorporated specializes in single-use medical devices primarily used in clinical settings. Their portfolio includes vinyl and nitrile examination and treatment gloves (both non-powdered and non-antimicrobial) as well as tracheostomy kits. These products are designed for use in surgical, diagnostic, and procedural environments to ensure hygiene and safety during medical interventions.

The company is based in the United States. As a U.S.-based manufacturer, their products are developed and distributed in compliance with applicable U.S. medical device regulations, including those governing safety, performance, and regulatory reporting.

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices through a standardized identification system.

The company’s devices fall into two primary classification categories under FDA regulations: Class I and Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with.

The company’s non-powdered gloves eliminate the risk of powder residue, which can cause allergic reactions or contamination in sensitive medical procedures. Non-antimicrobial gloves are designed for general use where antimicrobial properties are not required, reducing unnecessary exposure to antimicrobial agents. These specifications align with clinical needs for specific procedures, ensuring compatibility with patient safety and procedural requirements.