21 CFR § 878.4022 - Hydrogel wound dressing and burn dressing.

---
identifier: "/us/cfr/t21/s878.4022"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4022 - Hydrogel wound dressing and burn dressing."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4022"
section_name: "Hydrogel wound dressing and burn dressing."
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"
---


# 878.4022 Hydrogel wound dressing and burn dressing.

(a) *Identification.* A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

[64 FR 53929, Oct. 5, 1999]