KASHI SCIENTIFIC LLC

Kashi Scientific LLC specializes in three primary categories of medical devices: nitrile examination and treatment gloves (non-powdered and non-antimicrobial), cervical cytology brushes for gynecological specimen collection, and oral/upper respiratory tract swabs for diagnostic sampling. These products are designed for clinical and medical use, ensuring compatibility with standard healthcare procedures.

Kashi Scientific LLC is based in the United States. Since its devices fall under FDA jurisdiction, the company must comply with U.S. regulatory requirements for medical devices. This includes adhering to manufacturing standards, labeling guidelines, and registration processes specific to the FDA’s oversight, ensuring products meet safety and performance expectations for their intended use.

Kashi Scientific LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to identify medical devices, ensuring traceability, transparency, and easier tracking for regulatory and clinical purposes. This listing helps healthcare providers, regulators, and other stakeholders verify the identity and classification of the company’s products.

All of Kashi Scientific LLC’s devices are classified as Class I medical devices by the FDA. Class I devices are generally considered to pose the lowest risk to patients and are subject to the least regulatory control, though they still must comply with basic safety and performance requirements. This classification applies to products like gloves, cytology brushes, and swabs, which are designed for low-to-moderate-risk clinical applications.

Kashi Scientific LLC’s devices are primarily marketed and regulated within the United States, where the FDA’s UDI database serves as the authoritative registry for tracking medical devices. While some devices may have global applications, the company’s focus on FDA-compliant products means its listings are concentrated in U.S.-specific databases. Other registries (e.g., EUDAMED for the EU) would only include devices cleared or approved in those regions, which is not applicable here.