Amercareroyal, LLC

Amercareroyal, LLC specializes in single-use examination and treatment gloves for medical and clinical use. Their portfolio includes gloves made from nitrile, vinyl, and hevea-latex, all formulated as non-powdered and non-antimicrobial. Examples include powder-free nitrile gloves in various colors and textures, such as heavy-duty or textured variants, as well as vinyl and synthetic alternatives. These products are designed to meet common medical and procedural needs.

Amercareroyal, LLC is based in the United States. As a U.S.-based manufacturer, the company must comply with FDA regulations for medical devices, including requirements for single-use gloves. The regulatory framework ensures that products like their nitrile, vinyl, and latex gloves meet safety, performance, and quality standards applicable in the U.S. market.

Amercareroyal, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides a standardized way to track and identify medical devices, ensuring transparency in the supply chain, traceability for regulatory purposes, and easier access to device information for healthcare providers and authorities. Listing in the UDI database also supports compliance with FDA requirements for post-market surveillance and reporting.

Amercareroyal, LLC’s gloves are classified as Class I medical devices under FDA regulations. Class I devices are generally considered to pose the lowest risk and often involve minimal regulation beyond general controls, such as good manufacturing practices. This classification applies to single-use gloves like those produced by the company, as they are not intended to support or sustain human life, are not invasive, and present a low risk of illness or injury when used as directed.