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Aspen Glove obtains FDA's 510(k) clearance to sell latex gloves in the US

Atiqah Mokhtar
Atiqah Mokhtar • 1 min read
Aspen Glove obtains FDA's 510(k) clearance to sell latex gloves in the US
Aspen Glove will now be able to design, manufacture and distribute the gloves under the “Aspen Glove” trademark in the US market.
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Aspen (Group) Holdings has announced that its subsidiary Aspen Glove has obtained the 510(k) Premarket Notification clearance from the US Food and Drug Administration (FDA) to market latex examination powder free gloves.

See also: Aspen confirms US$210 million glove deal with Honeywell is off, looking for new buyers

With the 510(k) clearance, Aspen Glove will now be able to design, manufacture and directly distribute the gloves under the “Aspen Glove” trademark and third-party original equipment manufacturing (OEM) brand under OEM arrangements in the US market.

Shares in Aspen closed 2 cents or 15.9% higher at 14.6 cents on Sept 22.

Photo: Albert Chua/The Edge Singapore

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