USA: FDA announces guidance for protective clothing during COVID-19 outbreak
The US Food and Drug Administration (FDA), announced a guidance for the enforcement of protective apparel (gowns, gloves etc.) during the COVID-19 outbreak that is in immediate effect.
This guidance expands the availability of surgical apparel during the pandemic. Through this guidance, the FDA outlines policies for gowns, other apparel and gloves, and makes a delineation between what types of products require pre-market notifications.
For example, non-surgical gowns with minimum to low barrier protection is a class I device and exempt from notification requirements. However, the manufacturer is still subject to general controls including specific labeling and label recommendations for use.
How TSG can help
Our consultants have been working closely with federal agencies like the FDA to remain on top of all new policies and guidance released in response to this public health outbreak. TSG’s consultants have experience with 510(k) premarket notifications and can assist in determining whether your product needs one. Our consultants can also assist with labeling development and compliance.
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