← Product Code [MAC](/submissions/SU/subpart-e%E2%80%94surgical-devices/MAC) · K894455

# DECONTAMINATING KIT, SKIN: M291 (K894455)

_Dept. of the Army · MAC · Aug 15, 1989 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MAC/K894455

## Device Facts

- **Applicant:** Dept. of the Army
- **Product Code:** [MAC](/submissions/SU/subpart-e%E2%80%94surgical-devices/MAC.md)
- **Decision Date:** Aug 15, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4014
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MAC/K894455](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MAC/K894455)

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