(a) Identification. An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in Sec. 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of Sec. 820.180, with respect to general requirements concerning records, and Sec. 820.198, with respect to complaint files. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]