N.V. Kalibaru

N.V. Kalibaru specializes in manufacturing patient examination gloves made from latex. These gloves are intended for clinical use to help maintain hygiene and lower infection risks during medical procedures. The company focuses on this single product category, ensuring it meets regulatory standards for single-use protective barriers in healthcare settings.

N.V. Kalibaru is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s location ensures compliance with U.S. requirements, including classification under Class I and submission through pathways like the 510(k) process. This pathway is commonly used for devices deemed low-risk, such as examination gloves, to demonstrate substantial equivalence to a legally marketed predicate.

N.V. Kalibaru’s latex patient examination gloves are classified as Class I devices by the FDA. This classification is based on the agency’s risk-based system, where devices like gloves—used for non-invasive, low-risk applications—are grouped into the lowest regulatory category. Class I devices typically require general controls (e.g., good manufacturing practices) and may use the 510(k) pathway to demonstrate equivalence to an existing approved device, rather than undergoing rigorous pre-market approval.

N.V. Kalibaru’s devices are listed in the FDA’s 510(k) registry, which documents submissions for Class I and Class II devices seeking clearance through the 510(k) pathway. This registry serves as a public record of devices deemed substantially equivalent to a legally marketed predicate, ensuring transparency about their compliance status. While the company’s devices may also appear in other industry directories, the 510(k) listing is the primary FDA-recognized reference for this product.