Wildcat Ppe, LLC

Wildcat PPE, LLC specializes in single-use isolation gowns for healthcare environments. These gowns include standard surgical isolation gowns as well as variants with open-back and full-back designs, such as the Olimax/Wildcat Isolation Gown and Wildcat PE Surgical Isolation Gown. Their focus is on providing barrier protection for both patients and healthcare staff during medical procedures.

Wildcat PPE, LLC is based in the United States. Its devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system, ensuring traceability and regulatory compliance for its isolation gowns.

Wildcat PPE, LLC’s isolation gowns fall under Class I or Class II classifications in the US. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the gown’s intended use and potential risks.

Yes, Wildcat PPE, LLC’s isolation gowns are listed in the FDA’s 510(k) and UDI databases. These registries help track device performance, compliance, and market authorization status, ensuring transparency for healthcare providers and regulators.