Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5570](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5570) → KGB — Mask, Oxygen, Non-Rebreathing

# KGB · Mask, Oxygen, Non-Rebreathing

_Anesthesiology · 21 CFR 868.5570 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB

## Overview

- **Product Code:** KGB
- **Device Name:** Mask, Oxygen, Non-Rebreathing
- **Regulation:** [21 CFR 868.5570](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5570)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K970688](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K970688.md) | POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | Sep 26, 1997 | SESE |
| [K960401](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K960401.md) | ULTIMATE SEAL | Hans Rudolph, Inc. | Jun 20, 1996 | SESE |
| [K941336](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K941336.md) | COMBO MASK | Gam Industries, Inc. | Sep 9, 1994 | SESE |
| [K935917](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K935917.md) | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 4, 1994 | SESE |
| [K932347](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K932347.md) | COMPACT MASK | Vital Signs, Inc. | Jan 10, 1994 | SESE |
| [K933583](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K933583.md) | NONREBREATHING VALVE | Hans Rudolph, Inc. | Jan 3, 1994 | SESE |
| [K933048](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K933048.md) | LAERDAL(TM) POCKET MASK, MODIFICATION | Laerdal Medical Corp. | Dec 2, 1993 | SESE |
| [K930336](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K930336.md) | PROFAST(R)-DENTURE ADHESIVE CREAM | Fittydent-Altwirth & Schmitt GmbH | Aug 24, 1993 | SESE |
| [K913164](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K913164.md) | NON REBREATHING MASK | Specialty Packaging Producs, Inc. | Jan 15, 1992 | SESE |
| [K883766](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K883766.md) | MOUTH-TO-MASK VENTILATORY ADJUNCT | Medic One | Oct 21, 1988 | SESE |
| [K790162](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K790162.md) | OXYGEN MASK, CONCENTRATION AEROSOL MASK | Airlife, Inc. | Apr 20, 1979 | SESE |
| [K790161](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K790161.md) | OXYGEN MASK W/RESERVOIR BAG | Airlife, Inc. | Apr 20, 1979 | SESE |
| [K781414](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K781414.md) | MASK, OXYGEN, NONBREATHING | Vitalab Products Corp. | Sep 7, 1978 | SESE |

## Top Applicants

- Airlife, Inc. — 2 clearances
- Hans Rudolph, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Cheen Houng Ent. Co. , Ltd. — 1 clearance
- Fittydent-Altwirth & Schmitt GmbH — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB)

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