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HHS/FDA Make It Official: Premarket Notification Required For 7 Types Of Class I Medical Gloves

 
• By Shawn M. Schmitt

A joint final order from the US Department of Health and Human Services and the Food and Drug Administration says makers of the low-risk gloves must have 510(k) clearance before sending their products to market.

Closeup of professional doctor putting on blue latex gloves on hands.

The US Department of Health and Human Services (HHS) and the Food and Drug Administration said on 23 July that makers of seven types of low-risk class I medical gloves must submit premarket notifications to the agency before sending their products to market.

The HHS and the FDA made its determination official in a final order that will be published in the...

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