§ 878.4480 - Absorbable powder for lubricating a surgeon's glove.

§ 878.4480 Absorbable powder for lubricating a surgeon's glove.

Cross Reference

Link to an amendment published at 81 FR 91730, Dec. 19, 2016.

(a) Identification. Absorbable powder for lubricating a surgeon's glove is a powder made from corn starch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putting on a surgeon's glove. The device is absorbable through biological degradation.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.