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. The 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.
Surgical gowns must be worn by every doctor before performing an operation. Surgical gowns mainly focus on barrier properties, including the ability to prevent penetration of liquids and microorganisms. Therefore, the material of the surgical gown is very important.
The material of disposable surgical gown is SMS (Spunbond + Meltblown + Spunbond Nonwovens), which is a composite non-woven fabric with 3 layers, 2 layers of spunbond, and a layer of meltblown in the middle.
The technology includes spinning fibers into silk, and then directly diverging into a net through a baffle or airflow, without any chemical substances, and is thermally bonded; spunbond materials also have flame retardancy or antistatic properties. It has many characteristics, including: light weight, high strength, high air permeability, hydrophilicity and excellent abrasion resistance.
The meltblown process emerged after the spunbond technology and is a process that can produce ultra-fine filament (microfiber) nonwovens at low cost. The technique involves blowing hot air onto molten thermoplastic resin, which is extruded through a linear die containing hundreds of small holes to form a fine fiber self-adhesive nonwoven web. Its main feature is that it is a very fine fiber, therefore, this material is usually used for air, liquid and particle filters.
The combination of spunbond and meltblown materials means that their respective characteristics are efficiently combined and make up for each other's weaknesses. When made from this SMS material, it has strong water repellency, high tensile strength, softness, comfort, breathability, abrasion resistance, and light weight. It can also act as a water repellent and can block bacteria, blood and other liquids, as well as gas/steam sweat.
This becomes the best choice for disposable surgical gowns.
Wellmien provides globally medical care and food processing facilities with products including face masks, surgical gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, first-aid products,emergency blanket and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. If you have any needs, please do not hesitate to contact us!