← Product Code [EYF](/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF) · K910104

# ANTI-FOG DISPOSABLE IV INDUCTION COVER (K910104)

_Central Plastic, Inc. · EYF · Apr 12, 1991 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K910104

## Device Facts

- **Applicant:** Central Plastic, Inc.
- **Product Code:** [EYF](/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF.md)
- **Decision Date:** Apr 12, 1991
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K910104](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K910104)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com