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21 CFR 878.4470

§ 878.4470 Surgeon's gloving cream.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 878.4470, § 878.4470 Surgeon's gloving cream, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90435
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(a) Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove. (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 § 878.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.