Taipei, May 26 (CNA) Taiwan will ban the importation and manufacture of powdered medical gloves, with effect from 2021, because the powder can cause adverse health effects, the country's Food and Drug Administration (FDA) said Sunday.
Exposure to powdered gloves may cause allergic reactions, wound inflammation, adhesions, and increased risk of infection, said Wu Cheng-ning, a section chief at Taiwan's FDA, citing a ban that was issued in 2017 by the United States FDA.
Germany prohibited the use of powdered medical gloves as early as 1998, while Japan and the Philippines implemented a ban at the beginning of this year, Wu said, adding that the problem is the cornstarch content, which serves as a carrier of allergens.
Following a meeting of experts that was convened by Taiwan's FDA in 2017, it was concluded that the risks outweighed the benefits associated with the use of powdered gloves, Wu said.
The FDA, therefore, had planned to phase out the use of powdered gloves, starting with a ban on their importation and manufacture 2020, unless the manufacturers could produce scientific evidence that proved the gloves would not produce the known adverse effects, Wu said.
However, the FDA recently decided to postpone the ban until Jan. 1, 2021, after some manufacturers said that they had already signed supply contracts with hospitals through to next year for powered gloves and would require more time to adjust their licenses, packaging and other measures to comply with the new rules, according to Wu.
When the ban takes effect, all licenses for the manufacture of powdered gloves will be revoked, while suppliers will no longer be allowed to produce or import the gloves, he said.
Products legally manufactured or imported before Dec. 31, 2020, however, will be allowed to remain on the market, he added.
The penalties for violation of the regulations will range from fines of NT$60,000 (US$1,905) to NT$50 million and/or a prison sentence of up to three years, Wu said.
In Taiwan, powdered gloves cost about 40 percent less than other types and are used mainly in hospitals.
Between 2014 and 2016, some 10 million pairs of powdered surgical gloves were used in Taiwan, compared with 500,000-600,000 pairs of non-powdered ones, according to the country's FDA.
There are 22 manufacturers in Taiwan who hold 53 manufacturing licenses for surgical gloves -- 20 for powdered gloves and 33 for non-powdered gloves, according to Wu.
Meanwhile, there are 71 manufacturers of medical examination gloves, who hold 170 licenses, he said.
