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) → LZM — Guard, Skin Graft

# LZM · Guard, Skin Graft

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

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

## Overview

- **Product Code:** LZM
- **Device Name:** Guard, Skin Graft
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K943871](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LZM/K943871.md) | AQUAPLAST TIE DOWN DRESSING | Wfr/Aquaplast Corp. | Sep 30, 1994 | SESE |
| [K885136](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LZM/K885136.md) | GRAFT GUARD | Sorex Medical | Feb 6, 1989 | SESE |

## Top Applicants

- Sorex Medical — 1 clearance
- Wfr/Aquaplast Corp. — 1 clearance

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

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