Isolation Gowns

Chamfond isolation gowns are designed to protect against direct contact with body fluids. Our isolation gowns provide full coverage meet AAMI Level. The full-back design means that no part of the body is exposed to possible contamination, making the product appropriate for use in hospitals, laboratories, food production settings, etc.

It is made of a durable polypropylene material and have an elastic cuff to provide a secure fit. It is designed with a waist tie which helps to hold it around the waist while it’s being put on and taken off.

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

Standard AAMI PB70 Level 1
Back Style Full Back
Cuff Style Elastic Wrists
Neck Closure Tie
Material PP+PE
Latex Free Yes
Protection Level Fluid Resistance
Reusable or Disposable Disposable

 

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.

 

 

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