Staples, Inc.

Staples, Inc. specializes in single-use surgical and medical face masks. These masks are primarily designed for healthcare environments to provide barrier protection against airborne particles and bodily fluids during medical procedures. The focus is on disposable masks, ensuring hygiene and safety in clinical settings.

Staples, Inc. is based in the United States. Since its devices are manufactured domestically, they are subject to U.S. regulatory requirements, including classification under the FDA’s system. This means compliance with U.S. standards for safety, performance, and labeling is a key consideration for its products.

The devices produced by Staples, Inc., such as surgical and medical face masks, are classified as Class II under FDA regulations. This classification indicates that they pose moderate risks and require special controls beyond general controls to ensure their safety and effectiveness, such as performance testing and labeling requirements.

Yes, Staples, Inc.’s medical devices, including its single-use surgical and medical face masks, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify devices throughout their lifecycle, ensuring transparency and traceability in compliance with U.S. regulatory standards.