A ban on importing and manufacturing powdered medical gloves is to start in 2021, because the powder causes health problems, the Food and Drug Administration (FDA) said on Sunday.
Powdered gloves can cause allergic reactions, inflammation, adhesions and an increased risk of infection, Division of Medical Devices and Cosmetics section head Wu Cheng-ning (吳正寧) said, citing a ban issued by the US FDA in 2017.
Germany prohibited powdered medical gloves as early as 1998, while Japan and the Philippines implemented a ban at the beginning of this year, Wu said.
The cornstarch in the gloves relays allergens, he added.
A meeting of experts convened in 2017 concluded that the risks of using the gloves outweighed any benefits, Wu said.
The Taiwanese agency had planned to phase out the gloves, banning their importation and manufacture from 2020, unless manufacturers could produce scientific evidence proving the gloves did not have adverse effects, Wu said.
After manufacturers said that they had contracts with hospitals through next year and that they needed more time to comply with the planned change, it postponed the ban until Jan. 1, 2021, he said.
When the ban takes effect, all manufacturing licenses for powdered gloves will be revoked and importing them will be illegal, Wu added.
Only powdered gloves manufactured or imported before Dec. 31 next year are to remain on the market, Wu added.
Breaching the regulation could result in a fine of NT$60,000 to NT$50 million (US$1,908 to US$1.6 million) and a prison sentence of up to three years, Wu said.
Powdered gloves cost about 40 percent less than other types and are used mainly in hospitals.
From 2014 to 2016, about 10 million pairs of powdered surgical gloves were used, compared with 500,000 to 600,000 pairs of non-powdered ones, the agency said.
Twenty-two manufacturers hold 53 licenses for making surgical gloves — with 20 of them for powdered gloves, Wu said.
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