---
kind: "section"
citation: "21 C.F.R. § 878.4022"
title: "21"
number: "878.4022"
heading: "Hydrogel wound dressing and burn dressing."
url: "https://uscodex.org/cfr/21/878.4022"
---

# §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](/cfr/21/part807.md), [subpart E](/cfr/21/subpartE.md) of this chapter subject to the limitations in [§ 878.9](/cfr/21/878.9.md).

## Notes

### Amendments

[64 FR 53929, Oct. 5, 1999]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[64 FR 53929, Oct. 5, 1999]