Complaint
Disposable surgical gowns are clothes worn by surgeons and other medical staff during operations in the operating room. In addition, a disposable sterile gown protects the patient and healthcare workers from infection during the operation. Moreover, the disposable surgical gowns comply with international surgical gown standards such as EN13795 and AAMI PB70.
As a professional surgical gown manufacturer, we insist on selecting suitable materials, adopting advanced production techniques, and strict quality control systems to provide your medical staff with various types of sterile gowns online. In addition, we have set up production plants and workshops according to GMP requirements, and the purification and asepsis have reached 100000 or 300000 levels of the dust-free environment.
| material | nonwoven fabric&PP+PE&PP&SMS |
| wrist style | elastic wrist, thumb loop |
| Neck style | neck tie, over head style |
| color | blue&white etc. |
| size | 120-140cm etc. |
| inner pack | 100pcs/carton |
| OEM | available |
| certificate | ISO13485&CE |
| Advantage | Cheap/waterproof |
According to 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. As referenced in Figure 1: the critical zones include the front of the body from the 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 surgical gowns.
Source 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 are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.
All 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.
Source FDA
