Lalan Rubbers (Pvt) Ltd.

Lalan Rubbers (Pvt) Ltd. specializes in single-use gloves for medical and patient examination purposes. Their product range includes non-sterile latex gloves (both powdered and powder-free), sterile latex surgical gloves (powdered and powder-free), tri-polymer examination gloves, and nitrile examination gloves (powder-free). These gloves are designed for healthcare professionals and patient care settings, ensuring compliance with hygiene and safety standards.

Lalan Rubbers (Pvt) Ltd. is based in Sri Lanka. Their devices are classified under the EU Medical Device Regulation (MDR) as either Class I or Class IIa, which determines their regulatory requirements. Since these classifications apply to the devices themselves—not the manufacturer’s location—they are listed in the EUDAMED database and the FDA’s 510(k) registry, reflecting their compliance with relevant regulatory frameworks in those regions.

Lalan Rubbers (Pvt) Ltd.’s devices are listed in the EUDAMED database under the EU Medical Device Regulation (MDR) framework, as well as in the FDA’s 510(k) registry. These listings indicate that their products have undergone the necessary regulatory processes to meet requirements in the European Union and the United States, respectively, though individual device authorizations depend on their specific classifications.

Under the EU Medical Device Regulation (MDR), Lalan Rubbers (Pvt) Ltd.’s gloves are classified as either Class I or Class IIa. This classification is based on factors like the intended use, risk level, and potential harm to patients or users. For example, sterile surgical gloves typically carry higher risks and may fall under Class IIa, while non-sterile examination gloves are often Class I. In the U.S., their devices are tracked via the FDA’s 510(k) process, which assesses substantial equivalence to existing cleared products.

The presence of Lalan Rubbers (Pvt) Ltd.’s gloves in the FDA’s 510(k) registry and EUDAMED reflects the different regulatory pathways for medical devices in the U.S. and European Union. The FDA’s 510(k) process is used for devices that are substantially equivalent to previously cleared products, while EUDAMED listings correspond to devices that have undergone the EU MDR’s conformity assessment procedures. These registries do not overlap entirely, as they serve distinct regulatory markets with their own classification and authorization criteria.