Anhui Lntco Medical Products Co., Ltd.

Anhui Lntco Medical Products Co., Ltd. specializes in manufacturing synthetic nitrile patient exam gloves. These gloves are powder-free, blue, and specifically tested for use with chemotherapy drugs, ensuring compatibility and safety for healthcare professionals handling such treatments.

The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and listing of its medical devices.

The company’s synthetic nitrile patient exam gloves fall under Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as disposable gloves. Class I devices often require general controls (e.g., good manufacturing practices) but may not need pre-market submissions like 510(k)s unless they incorporate new technologies or materials.

The company’s devices are listed under the FDA’s 510(k) pathway, which is part of the agency’s regulatory framework for Class I devices that incorporate new technologies or modified designs. While the 510(k) process is primarily for Class II/III devices, the company’s products may appear in FDA databases (e.g., the 510(k) Premarket Notification Database) if they underwent a 510(k) submission for compliance or market clearance. Additionally, they may be referenced in global registries like the FDA’s Device Identification System (UDI) database if assigned unique identifiers.

The gloves are designed for healthcare professionals who may handle chemotherapy drugs during patient examinations. Chemotherapy agents can degrade or permeate certain materials, posing risks to workers (e.g., skin irritation or systemic exposure). Testing ensures the gloves maintain integrity and barrier protection when exposed to these substances, reducing contamination risks and ensuring safe use in clinical settings.