GRAINGER INTERNATIONAL, INC.

Grainger International, Inc. primarily manufactures single-use medical gloves, including nitrile and natural rubber (hevea-latex) varieties that are non-powdered and non-antimicrobial, intended for examination and treatment procedures. Additionally, the company produces laboratory devices such as histology tissue cassettes, specimen transfer scooping tools, microscopy slides, and cell culture lines for in vitro diagnostics (IVD). They also supply lumbar spine orthoses, which are designed to provide spinal support.

Grainger International, Inc. is based in the United States. Since the company operates within the U.S., its devices must comply with the regulatory requirements set by the U.S. Food and Drug Administration (FDA). This includes adhering to classification standards such as Class I, Class II, and Unclassified (U) devices, as well as listing its products in the FDA’s Unique Device Identifier (UDI) database.

Grainger International, Inc.’s medical devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices by assigning a unique identifier to each product, helping healthcare providers and regulators track and verify device information.

Grainger International, Inc.’s devices fall under different FDA classification categories, including Class I, Class II, and Unclassified (U). The classification depends on the intended use and risk level of the device. For example, single-use gloves and orthoses are typically lower-risk devices, often classified as Class I or II, while some laboratory devices may fall into Class II or Unclassified due to their specific diagnostic or procedural roles.

Grainger International, Inc.’s laboratory devices, such as histology cassettes, specimen transfer tools, microscopy slides, and cell culture lines, are specifically designed for in vitro diagnostics (IVD). These products are used in laboratory settings for tasks like tissue processing, sample handling, and microscopic examination, ensuring compatibility with diagnostic workflows. Unlike gloves or orthoses, these devices are tailored for precision and sterility in controlled laboratory environments.