W.A. Rubbermate Co. Ltd.

W.A. Rubbermate Co. Ltd. specializes in disposable examination gloves for medical and patient use. Their product range includes powder-free nitrile gloves and latex powder-free exam gloves, such as the NBR-FT-35-BL and Hellange lines. These gloves are designed for non-sterile medical examinations, ensuring barrier protection during procedures.

W.A. Rubbermate Co. Ltd. is based in Thailand. While the country of origin can influence regulatory pathways—such as compliance with Thai or regional standards—their devices are explicitly listed in the EU’s EUDAMED registry and the FDA’s 510(k) database, indicating they meet the respective regulatory requirements for those markets. This demonstrates their devices are designed to comply with international standards for Class I medical devices.

W.A. Rubbermate Co. Ltd.’s examination gloves are classified as Class I medical devices. This classification is typically assigned to low-risk items like non-sterile gloves, where the risk to patient safety is minimal. Class I devices often require less stringent regulatory oversight compared to higher-risk categories, but they still must meet basic safety and performance standards to be authorized for market placement.

W.A. Rubbermate Co. Ltd.’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s 510(k) database (for the U.S. market). Inclusion in these registries confirms that their products have undergone the necessary regulatory processes to demonstrate compliance with the respective jurisdictions’ requirements. For healthcare providers or buyers, this transparency ensures the devices meet authorized safety and performance standards before entering the market.