Medtecs
Disposable Surgical Gown

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.

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.

According to FDA, a surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. 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 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.

Medtecs Disposable Surgical gowns are suitable for normal storage conditions, such as in their original packaging, which should be kept dry, clean, and dust-free. Uncontaminated coveralls can be safely disposed of through incineration or burial in controlled landfills without causing harm to the environment. However, the disposal of contaminated garments should comply with local laws and regulations in the relevant country or region.

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