Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4014](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4014) → EYF — Protector, Wound, Plastic

# EYF · Protector, Wound, Plastic

_General, Plastic Surgery · 21 CFR 878.4014 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF

## Overview

- **Product Code:** EYF
- **Device Name:** Protector, Wound, Plastic
- **Regulation:** [21 CFR 878.4014](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4014)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

## Classification Rationale

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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K922785](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K922785.md) | IRRIVAGE | Autovage | Oct 16, 1992 | SESE |
| [K911407](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K911407.md) | HARDING STERNAL SHIELD | Harding Medical Devices | Jul 5, 1991 | SESE |
| [K910104](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K910104.md) | ANTI-FOG DISPOSABLE IV INDUCTION COVER | Central Plastic, Inc. | Apr 12, 1991 | SESE |
| [K904389](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K904389.md) | SI-PRO | David F. Trungale | Dec 17, 1990 | SESE |
| [K832908](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K832908.md) | COMFEEL PROTECTIVE RINGS | Coloplast A/S | Dec 12, 1983 | SESE |

## Top Applicants

- Harding Medical Devices — 1 clearance
- David F. Trungale — 1 clearance
- Coloplast A/S — 1 clearance
- Central Plastic, Inc. — 1 clearance
- Autovage — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF)

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