With guidance from the State of Massachusetts Manufacturing Emergency Response Team (M-ERT), we have developed a Polyethylene (PE) film, full-back, easy-off, non-surgical isolation gown. It has been deployed to healthcare providers and staff in Massachusetts and now is also available here to those in need of such equipment. These gowns provides minimal-barrier protection as captured by ANSI/AAMI PB70 of at least level 2.
Sold in case pack boxes of 80 pcs. (box dimensions 18" x 14" x 13"). Available for US shipment only. Free shipping in the US.
For orders over 10 boxes or for international needs, please contact firstname.lastname@example.org.
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 2 requirement for ANSI/AAMI PB70
- Testing: AATCC127 passed the Level 2 requirement for ANSI/AAMI PB70
- This product can be wiped off using 70% Isopropyl Alcohol. Other cleaning products are not recommended.
- The article has not been FDA cleared or approved, it is a Class I Medical Device that is exempt from the FDA's section 510(k) premarket notification requirements.
CAUTION: This product is not intended for use in a surgical setting or in an environment where significant exposure to bodily liquid or other hazardous fluids may be expected, including where large quantities of liquid droplets or any quantity of aerosols are generated or expected. This product should not be used in the presence of high intensity heat sources or flammable gas.
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.