Surgical overalls are FDA-regulated Class II medical devices that require 510(k) clearance before being marketed. They are a type of personal protective equipment designed to be worn by healthcare personnel during surgical procedures to protect patients and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate matter. Because of the controlled nature of surgical procedures, the national standards have described the critical protective areas. Key areas include the front of the body from the top of the shoulders to the knees and the arms from the wrist cuffs to above the elbows. Surgical overalls can be used for any risk level (Levels 1 through 4). All surgical overalls must have labels attached to them.
Isolation surgical overalls: Use surgical isolation gowns when there is a moderate to high risk of contamination and a need for larger critical areas than conventional surgical overalls. Like surgical overalls, surgical isolation gowns are FDA-regulated Class II medical devices that require 510(k) clearance before being marketed. Except for straps, cuffs, and hemlines, all areas of the surgical isolation gown are considered critical protective areas and must meet the highest liquid barrier protection level rated for isolation gowns. All seams must provide liquid barrier protection equivalent to that of the rest of the gown. Additionally, the fabric of surgical isolation gowns should cover as much of the body as possible to fit the intended use.
Non-surgical overalls are Class I devices (exempt from premarket review) designed to protect wearers from the transfer of microorganisms and bodily fluids in situations of low or minimal risk of patient isolation. Non-surgical overalls should not be worn during surgical, invasive, or moderate-to-high-risk contamination situations. Like surgical isolation gowns, non-surgical overalls should also cover as much of the body as possible to fit the task. Except for straps, cuffs, and hemlines, all areas of non-surgical overalls are considered critical protective areas and must meet the highest liquid barrier protection level rated for isolation gowns. All seams must provide liquid barrier protection equivalent to that of the rest of the gown.
Labels indicating that the product has been tested and meets appropriate performance standards are one way for users and purchasers to determine when to use a particular surgical overall. Surgical overalls are tested using performance consensus standards:
The American Society for Testing and Materials (ASTM) F2407 is a comprehensive document that describes the testing of surgical overalls for tear resistance, seam strength, linting, water vapor permeability, and liquid barrier performance. The following is a summary of the FDA-approved ASTM F2407 standards: Tensile strength: ASTM D5034, ASTM D1682; Tear resistance: ASTM D5587 (woven), ASTM D5587 (nonwoven), ASTM D1424; Seam strength: ASTM D751 (elastic warp knit or woven). The American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes the liquid barrier performance and classification of protective clothing and drapes used in healthcare facilities.