Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5450](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5450) → LGM — Chamber, Patient Isolation

# LGM · Chamber, Patient Isolation

_General Hospital · 21 CFR 880.5450 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM

## Overview

- **Product Code:** LGM
- **Device Name:** Chamber, Patient Isolation
- **Regulation:** [21 CFR 880.5450](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5450)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231256](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K231256.md) | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | Jan 3, 2024 | SESE |
| [K163223](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K163223.md) | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | Nov 2, 2017 | SESE |
| [K080117](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K080117.md) | PATIENT ISOLATION UNIT, MODEL G019-1000 | Gentex Corporation | Jan 30, 2009 | SESE |
| [K022260](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K022260.md) | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | Isolation Systems, Inc. | Aug 29, 2002 | SESE |
| [K944133](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K944133.md) | MTB 1043 TREATMENT BOOTH | Mark Solutions, Inc. | Sep 7, 1995 | SESE |
| [K912444](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K912444.md) | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | Radiometer America, Inc. | Feb 18, 1992 | SESE |
| [K896721](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K896721.md) | MODEL 7-AT TREATMENT CHAMBER | J. H. Emerson Co. | Jan 22, 1990 | SESE |
| [K884295](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K884295.md) | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | Saybrex Intl., Inc. | Nov 8, 1988 | SESE |
| [K874306](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K874306.md) | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | Busse Hospital Disposables, Inc. | Mar 22, 1988 | SESE |
| [K864116](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K864116.md) | ANAGO ISOLATION MASK (#80-950) | Anago, Inc. | Nov 25, 1986 | SESE |
| [K831062](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K831062.md) | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | Apr 13, 1983 | SESE |
| [K790657](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM/K790657.md) | STRETCHER TRANSIT ISOLATER #122 | Vickers America Medical Corp. | Jul 3, 1979 | SESE |

## Top Applicants

- American Threshold Industries, Inc. — 1 clearance
- Anago, Inc. — 1 clearance
- Busse Hospital Disposables, Inc. — 1 clearance
- Carecubes, Inc. — 1 clearance
- Gentex Corporation — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGM)

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