Ultralight Reusable Medical Isolation Gown

Gown Details:

• Waterproof
• Launder for 25-100 uses
• AAMI Level 2

Features:

• Neck binding with ties
• Back opening binding ties
• Inside binding ties
• Binding ties to cinch waist back
• 4” Knit Wrist Cuff (easy to use with gloves)

Fabric Details:

• 100% Waterproof/Breathable Nylon
• 70D Shadowbox ripstop weave
• Ultralight 1.9oz/sq yard
• DWR Hot Calendar process coating meets ASTM Rainwear specifications

Fabric Testing:

• Air Permeability / ASTM D747 / AVG 2
• Impact penetration/AATCC42/Level 3
• Tearing Strength Warp / ASTM D1424 / Avg 4.5
• Tearing Strength Filling / ASTM D 1424 / Avg 3.2
• Seam Spillage Warp / No seam spillage
• Seam Spillage Warp Filling / No seam spillage

Regulatory:

This product meets the technical performance standards established by the FDA but has not been FDA cleared or approved

This product has been authorized by the FDA under an Emergency Use Authorization (EUA) for use as PPE in healthcare settings by Healthcare Personnel (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 COVID-19.

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.