Disposable Surgical Gowns – Non-Sterile

Features

EN ISO: 13485:2016
Registration Number: SX 60128518 0001
Classification: II
Product Code: FYA
Regulation Number: 21 CFR 878.4040
510k Number: K100971

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.  

According to the FDA, “A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. . . .  [T]he critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow.  Surgical gowns can be used for any risk level (Levels 1-4).  All surgical gowns must be labeled as a surgical gown.” 

Blueflame Medical’s Disposable Surgical Gowns (Non-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 (Non-Sterile) are vetted twice for quality assurance and best practice in line with these standards. 

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