THAI RUBBER GLOVES COMPANY LIMITED - BRANCH

The company produces single-use examination and treatment gloves, specifically Hevea-latex and nitrile varieties. These gloves are non-powdered and include antimicrobial properties to help reduce microbial contamination during medical, dental, and laboratory procedures.

The company operates as a branch in the United States, though its parent organization is based in Thailand. This branch handles manufacturing, distribution, or regulatory compliance for its U.S.-listed devices.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I medical devices, ensuring traceability and compliance with U.S. regulatory requirements.

The gloves fall under Class I medical device classification, which applies to low-risk items like single-use examination and treatment gloves. This classification is determined by their intended use and risk profile, as outlined in FDA guidelines.

The antimicrobial treatment helps inhibit microbial growth on the glove surface, reducing the risk of contamination during procedures. This feature is particularly useful in medical, dental, and laboratory settings where sterility is critical.