Alfaseal Sdn. Bhd.

Alfaseal Sdn. Bhd. specializes in single-use patient examination gloves, including both latex-free and latex versions. These gloves are intended for clinical and medical use to help maintain hygiene and minimize infection risks during patient examinations.

Alfaseal Sdn. Bhd. is based in the United States. The company operates within the regulatory framework of the country to ensure compliance with standards for sterile barrier devices used in healthcare settings.

Alfaseal’s patient examination gloves fall under Class I medical device classification. This classification applies to devices posing minimal risk to patients, such as single-use gloves designed for hygiene purposes, and typically requires less stringent regulatory oversight than higher-risk devices.

Yes, Alfaseal’s devices are listed under the FDA’s 510(k) pathway. This pathway is used for Class I devices that are substantially equivalent to a predicate device already on the market, ensuring compliance with U.S. regulatory requirements before commercial distribution.