Wuhan youfu company produce all isolation gowns totally baes on the AAMI PB70 standards.
And has got level 1 test reports for PP plus PE and SMS isolation gowns. And level 2 report for PP plus PE, SMS and CPE isolation gowns. Level 3 report for CPE gown.
The FDA recognizes guidelines from the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, which specify tests and results necessary to verify and validate that gowns provide specific levels of protection.
Here as below are the differences of the AAMI PB70 four levels of isolation gown:
Level 1 – Minimal risk
Level 1 gowns offer low levels of barrier protection, meaning they should only be used when the risk of fluid exposure is minimal. They are often worn by hospital visitors or by doctors and nurses during check-ups and non-invasive procedures.
Level 2 – Low risk
These gowns are more effective at blocking fluids than level 1 gowns. They can stand up to contact with fluid that occurs through splashes or splatters. Level 2 gowns are tested stringently to ensure they perform adequately. They are suitable for tasks that have a low risk of fluid penetration, such as drawing blood or doing rounds in the ICU.
Level 3 – Moderate risk
Level 3 gowns offer the wearer a good level of protection and are designed for use in moderate-risk medical scenarios. They are frequently worn in the emergency room (ER) and for invasive procedures such as arterial blood draws or inserting intravenous (IV) lines. They are tested to ensure efficacy against liquid soakage and splatters.
Level 4 – High risk
Level 4 gowns are designed for medium to high-risk medical scenarios. They offer the highest level of liquid barrier protection and are the go-to gowns for surgeries and other fluid-intensive procedures. These gowns are heavy-duty, preventing bodily fluids and bacterial pathogens from penetrating the garment for up to one hour.
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