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) → OVR — Kit, First Aid, Talking

# OVR · Kit, First Aid, Talking

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

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

## Overview

- **Product Code:** OVR
- **Device Name:** Kit, First Aid, Talking
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110625](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OVR/K110625.md) | SAFETYMATE TALKING FIRST AID | Safetymate, Inc. | Jun 17, 2011 | SESE |

## Top Applicants

- Safetymate, Inc. — 1 clearance

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

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