PPE Emergency Use Authorization (EUA) Regulations
Due to the shortage of PPE, we are manufacturing various products. At this time, our products are not FDA cleared or approved. Please read the EUA regulations below on each product.
Kaas Tailored FDA/EUA Disclaimer
We are required by the FDA to disclose the following information about the products that are currently being shared:
- The product has not been FDA cleared or approved
- The product has been authorized by FDA under an EUA for use by healthcare providers as personal protective equipment
- This product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.