Mah Sing Healthcare’s Nitrile Gloves Get FDA’s 510(k) Clearance

Mah Sing Healthcare has received the FDA’s 510(k) clearance for its nitrile examination gloves.

The Malaysia-based company says it can manufacture up to 3.68 billion pairs of gloves per year and it expects the global demand to remain strong through 2023.  

Mah Sing Healthcare has also received a license from Health Canada for the gloves and is now seeking a certification of conformance with the EU’s Medical Devices Regulation.