{"data":{"id":"us/21-cfr-880.5450","jurisdiction":"us","citation":"21 CFR 880.5450","heading":"Patient care reverse isolation chamber.","body":"(a) 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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart F—General Hospital and Personal Use Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"7fab9740dbc01a545f9af5ab83970d16feeea836ddfb628beae9ecc5466b0788","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.5445","next":"us/21-cfr-880.5475"},"notice":"GroundRules: Original legal text. Not legal advice."}