Comfort Rubber Gloves Industries Sdn. Bhd. - FDA 510(k) Cleared Devic...

Comfort Rubber Gloves Industries Sdn. Bhd., manufactures examination gloves for healthcare settings. The company operates with a manufacturing facility in Matang, Malaysia.

The company has received 15 FDA 510(k) clearances from 15 total submissions since 1994. All submissions focus on General Hospital devices. The latest clearance was granted in 2025, confirming active regulatory engagement.

Product specialization centers on powder-free examination gloves in multiple materials and colors. Recent cleared devices include nitrile and natural rubber latex formulations. Many products are tested for compatibility with chemotherapy drugs and feature low dermatitis potential claims.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by T. Cunningham Consulting & Associates, LLC as regulatory consultant.