Alpha Glove Sdn. Bhd.

Alpha Glove Sdn. Bhd. specializes in single-use medical examination gloves, specifically the Excel Latex Patient Examination Gloves. These gloves serve as a barrier protection product to minimize cross-contamination risk during medical examinations and procedures.

Alpha Glove Sdn. Bhd. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as its products are designed and manufactured with U.S. regulatory standards in mind.

Alpha Glove Sdn. Bhd.’s devices, including the Excel Latex Patient Examination Gloves, are listed in the FDA’s 510(k) database. This registry is used to track Class I medical devices that have undergone the 510(k) clearance process, demonstrating compliance with U.S. regulatory requirements.

Alpha Glove Sdn. Bhd.’s products fall under Class I medical device classification, which is the lowest risk category under FDA regulations. This classification applies because the gloves are considered low-risk single-use items with minimal potential for harm when used as intended, such as for barrier protection during examinations.