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FDA divides medical gowns into three categories. A surgical gown is intended to be worn by health care personnel during surgical procedures. Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones of protection. Non-surgical gowns are worn in low or minimal risk situations. [5]
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10] In the 1970s, Congress responded to the public's desire for additional oversight over medical devices by passing the Medical Device Amendments of 1976 (MDA) to the FD&C.
In 1970, the study committee recommended a classification for medical devices based on comparative risk. [5] In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States, [6] which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295. [7]
Over this was worn a tie-back or bouffant-style cloth cap, a gauze or synthetic textile mask, a cloth or synthetic surgical gown, latex gloves, and supportive closed-toe shoes. This uniform was originally known as "surgical greens" because of its color, but came to be called "scrubs" because it was worn in a "scrubbed" environment.
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