Food and Drug Administration held a meeting in 2017 regarding technical literatures of powder used in manufacturing process which may cause serious adverse effect directly or passively to end-users or patients. Moreover, invasive powered surgical gloves are considered to be a high risk-classification. The meeting resulted in an agreement to ban powered surgical gloves, which should be implemented within 3 years starting from 2017.
In 2020 Food and Drug Administration - a consumer protection organization - informed all parties regarding certain control measures banning powdered surgical gloves. Food and Drug Administration will soon officially publish Ministry of Public Health Announcement on Prohibition of Manufacturing, Importation or Sale of Powdered Surgical Gloves (2020). The ban enforces:
- 1. Powdered surgical gloves are medical devices that are prohibited from manufacturing, importation or sale.
- 2. Powdered surgical gloves for exportation only, shall be exempted from the announcement.
Food and Drug Administration Announcement Regarding Certain Control Measures for Powdered Surgical Gloves