Description

Features

● Comfortable design and made by fluid-resistant non-woven material
● Full back with ties at waist and neck provides easy on and off.
● Elastic cuffs offer protection against liquid and extra comfort.
● For blood and bodily fluid penetration
● For non-surgical applications

Specifications

Below is the summary of AAMI PB70:2012 level 1 standard recognized by the FDA.

Used for MINIMAL risk situations
Provides a slight barrier to small amounts of fluid penetration
Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
Applicability: basic care, standard hospital medical unit

The difference between non-surgical gowns and surgical isolation gowns

Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.

Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.