Glove One, LLC - FDA 510(k) Cleared Devices

Glove One, LLC is an American manufacturer of nitrile examination gloves based in Greenville, South Carolina. The company specializes in producing General Hospital devices, specifically powder-free nitrile gloves formulated for medical and protective applications. Glove One is a subsidiary of Health Supply US and operates a state-of-the-art manufacturing facility designed to produce over 4 billion gloves annually.

The company has received 1 FDA 510(k) clearance from 1 total submission since 2025. Glove One's cleared device includes powder-free nitrile examination gloves tested for use with chemotherapy drugs and fentanyl. The company remains actively engaged in regulatory compliance and product development within the General Hospital device category.

Glove One received a $137 million Department of Defense contract to expand domestic nitrile glove production. The company is committed to restoring American manufacturing capacity and reducing reliance on foreign PPE suppliers. The facility supports hospital networks, clinical settings, dental practices, and government agencies.

Explore the company's cleared device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Terrie M Heidemann as regulatory consultant.