Thailand: Surgical Mask Standards & Ban of Powered Surgical Gloves

Surgical Mask:

Alongside with the set of COVID-19 related medical device announcement, FDA had announced a list of standards to be complied by disposable surgical masks. This list has been provided as an attachment to the announcement. Applicants who wish to get their surgical masks registered for sale must comply to at least 1 of the standards that fall under this list.

Powered Surgical Gloves:

In order to prevent danger and protect the safety of patients arising from the use of powered surgical gloves, Thai FDA has prohibited the manufacturing, importation and sale of it from 5th November 2020 onward. It was found that the use of such gloves can cause adverse effects such as allergic reactions, inflammation of the inflammation of the respiratory tract, wound inflammation and fibrosis.


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