21 C.F.R. § 878.4460

Non-powdered surgeon's glove.

Last amended: 2017Year: 2026Length: 77 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 878.4460 (2026)

(a) Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. (b) Classification. Class I (general controls). [53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016]
21 C.F.R. § 878.4460: Non-powdered surgeon's glove. | Justis AI