BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

BP Pharmaceuticals Laboratories Unlimited Company specializes in single-use medical devices primarily focused on infection control and wound care. Their product line includes surgical and examination gloves made from hevea latex, nitrile, and vinyl—all non-powdered and non-antimicrobial—along with general-purpose and radiopaque woven surgical sponges, non-adhesive device retention bandages, and non-woven gauze pads. These items are designed for use in clinical settings to reduce contamination risks and support patient care.

BP Pharmaceuticals Laboratories Unlimited Company is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification under FDA’s Class I (low-risk) and Class II (moderate-risk) categories. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. medical device requirements.

BP Pharmaceuticals Laboratories Unlimited Company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a standardized identifier to medical devices to improve tracking, transparency, and regulatory oversight. This listing helps healthcare providers and regulators verify device details, such as manufacturer information and classification.

The FDA classifies BP Pharmaceuticals Laboratories Unlimited Company’s devices under Class I (for low-risk items like general-purpose surgical sponges and non-woven gauze pads) and Class II (for moderate-risk items such as surgical gloves and retention bandages). Classification determines the regulatory controls applied—Class I devices typically require general controls, while Class II may involve additional performance standards or post-market surveillance to ensure safety and effectiveness.