Level 2 Isolation Gown, Blue, Pack of 10
FDA GUIDANCE: This product has been authorized by FDA under an Emergency Use Authorization (EUA) for use as PPE in healthcare settings by HCP as they may help protect HCP and/or patients from the transfer of the SARS-CoV-2 virus in low or minimal risk level situations to prevent the spread of COVID19. 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.
Materials: 100% Polyethylene film
Description: Non-Surgical Isolation Gown
This article is Non-Sterile.
This article is intended for Single Use.
Testing: AATCC42 passed the Level 1/2/3 requirement for ANSI/AAMI PB70
Testing: AATCC127 passed the Level 2/3 requirement for ANSI/AAMI PB70
This product can be wiped off using 70% Isopropyl Alcohol. Other cleaning products are not recommended.