Guangzhou Hicare Medical Equipment and Materials Co., Ltd

Guangzhou Hicare Medical Equipment and Materials Co., Ltd specializes in single-use face splash shields. These are lightweight, disposable barriers designed to protect healthcare workers from fluid exposure during medical procedures, particularly in settings where splash or spray risks are present. The shields are intended for one-time use in clinical environments.

The company operates from the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices marketed in the US.

The company’s face splash shields are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and clinical purposes.

The company’s face splash shields fall under Class I device classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as single-use barriers like splash shields. Class I devices often require less stringent regulatory oversight compared to higher-risk categories.