Disposable Surgical Gowns – Sterile

Features

Status: Available
Model: Isolation Gown or Prevalent
CE Product Code: TMDDMJ2003123551-AG02-78
FDA Owner Operator Number: 10063149
Regulation Number: 21 CFR 878.4040

Category:

Description

Disposable Surgical Gowns are an important piece of personal protective equipment (PPE) used to protect the wearer from from the spread of disease if that person comes into contact with potentially infectious liquids or solid materials. They also help to prevent the wearer from spreading microorganisms to the patient. Surgical gowns are a critical piece of protective equipment for healthcare workers treating and/or coming into contact with Covid-19-infected individuals. Sterile surgical gowns, also known as “isolation gowns,” provide greater protection than non-sterile gowns for situations in which there is a medium to high risk of contamination.

According to the FDA, “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. . . .  [A]ll areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.” 

Blueflame Medical’s Disposable Surgical Gowns (Sterile) meet FDA guidelines for Class II personal protective equipment (PPE) and meet requirements for tensile strength, tear resistance, seam strength, lint generation, and water vapor transmission.  While brand name may change at any time, Blueflame guarantees all of its Disposable Surgical Gowns (Sterile) are vetted twice for quality assurance and best practice in line with these standards. 

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