21 CFR § 878.4460 - Non-powdered surgeon's glove.

---
identifier: "/us/cfr/t21/s878.4460"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4460 - Non-powdered surgeon's glove."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4460"
section_name: "Non-powdered surgeon's glove."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 878.4460 Non-powdered surgeon's glove.

(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]