Tri-Layer SMS AAMI Level 2 Isolation Gown*

*This product is authorized for sale under a US FDA Emergency Use Authorization (dated May 22, 2020) as a Non-Surgical Isolation Gown (Class I, 510(k) exempt medical device). The product is intended for use by healthcare professionals (HCPs) as personal protective equipment (PPE) in healthcare settings as they may help protect HCPs and/or patients from the transfer of the SARS-CoV-2 virus (COVID-19) in low or minimal risk level situations. The product has not been FDA cleared or approved. This product is non-sterile and has been tested to AAMI guidelines and meets Level 2 standards for spray impact penetration and hydrostatic pressure to help protect against fluid penetration from splashes, fluid absorption or soaking of liquids. The product is not intended for use in surgical settings or in other settings where the risk level for exposure to microorganisms, bodily fluids and particulate material is moderate to high, when a Level 3 or Level 4 Surgical or Surgical Isolation Gown is required. This product is intended for single-use and should only be worn by one person and must not be shared. This product cannot be laundered or disinfected and must be discarded after use per healthcare facility procedures. Always follow the intended use guidance and instructions. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. 510(k) authorization pending.

**Recommendations adapted per FDA guidelines https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns (03/11/2020)

***Testing data on file