Class I gowns as classified by the FDA, including but not limited to:

    • Non-Surgical Gowns
    • Isolation Gowns
    • Cover Gown
    • Procedure Gown
    • Patient Gowns

Class II gowns as classified by the FDA, for invasive procedures, including but not limited to:

    • Surgical Gowns

Class I: Devices are subject to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.

     The device is considered to be a class I exempt device because general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and the device is not intended for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury, under sections 513(a)(1)(A) and 510(l)(1) of the FD&C Act.

Class II: Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

•A 510(k) is a premarket submission made to FDA to demonstrate that the new device to be marketed is “substantially equivalent” to a legally marketed device.

•Manufacturers must compare their new device to a similar legally marketed device to support its substantial equivalence.

Classification: FDA Class I (exempt from premarket review).

Justification: Protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations.

•Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination. 

Coverings: Cover as much of the body is appropriate. All areas of the non-surgical 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. 

Seams: All seams must have the same liquid barrier protection as the rest of the gown. 

Classification: FDA Class II medical device that requires a 510(k) premarket notification.

•510(k) premarket notification that indicates the product is safe, effective, and is very similar as a legally marketed         from top of shoulders to knees and the arms from the wrist cuff to above the elbow. 

Levels: Surgical gowns can be used for any risk level (Levels 1-4).

  • The entire front of the gown (areas A,B and C) is required to have a barrier performance of at least level 1
  • The critical zones compromises at least areas A and B
  • The back of the surgical gown (area D) may be nonproductive
  • Levels 1 – 4

•Purpose of gown use: Isolation gowns are preferred, especially if there is potential contamination of the arms.

•Gowns should fully cover the torso, fit comfortably over the body, and have long sleeves that fit snugly at the wrist.

•Material

•Isolation gowns are made either of cotton or a spun synthetic material that dictate whether they can be laundered and reused or must be disposed.

•Cotton and spun synthetic isolation gowns vary in their degree of fluid resistance, another factor that must be considered in the selection of this garb.

•If fluid penetration is likely, a fluid resistant gown should be used.

•Patient Risk

•Clean gowns are used for isolation.

•Sterile gowns are only necessary for performing invasive procedures, such as inserting a central line.

•Microbial and fluid resistance

•Resistance to tears and punctures

•Comfort; fit loosely and comfortably to prevent excess heat build up.

•Durability, particularly related to repeated sterilization of non-disposable materials

•Gowns, in particular gowns composed of reusable woven material, are free of toxic substances, such as dyes and laundry detergent residues.

•Flammability resistance

•Lint free

•Woven fabrics with a high-thread count should be considered a non-effective barrier after approximately 75 reprocessing.

•Woven fabrics with a thread count of 270 to 280 be used as sterile gowns.