Indaljim, S.A. de C.V.

Indaljim, S.A. de C.V. specializes in single-use protective apparel for medical and public health settings. Their most common products include isolation gowns, surgical coveralls, surgical gowns for sterile procedures, public face masks, shoe covers, and surgical caps. These items are designed to maintain hygiene and infection control standards in clinical and public environments.

Indaljim, S.A. de C.V. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s regulatory framework. This means their products must comply with U.S. requirements for safety, performance, and labeling, though individual devices—not the company—are authorized for use.

Indaljim, S.A. de C.V.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices by assigning a unique code to each product, ensuring transparency and traceability in the healthcare supply chain.

Indaljim, S.A. de C.V.’s devices fall under FDA’s Class I and Class II (N) categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II (N) devices, such as some surgical gowns or face masks, may require additional performance standards or post-market surveillance due to moderate risk. Classification determines the regulatory pathway for authorization.