"Selection and use of protective apparel and surgical drapes in health care facilities"

This standard establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.

This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices.

A compendium of information or series of options that does not recommend a specific course of action: A guide increases the awareness of information and approaches in a given subject area.

All items of clothing and/or accessories (whether or not detachable) designed and manufactured to provide specific protection. This includes bullet-proof clothing, general protective clothing and full body ensembles that protect from cuts, radiation, temperature extremes, hot splashes from molten metals and other hot liquids, potential impacts from tools, machinery and materials and hazardous chemicals. Examples of body protection include laboratory coats, coveralls, vests, jackets, aprons, surgical gowns and full body suits

• Medical protective clothing

• Biological