{"data":{"id":"us/21-cfr-868.5570","jurisdiction":"us","citation":"21 CFR 868.5570","heading":"Nonrebreathing mask.","body":"(a) 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.\n(b) Classification. 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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 868—ANESTHESIOLOGY DEVICES","Subpart F—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":"0c40873b5d1b19a0c80facac11aae0c3a3cea8b39c5c11822ecdbbb66873747e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5560","next":"us/21-cfr-868.5580"},"notice":"GroundRules: Original legal text. Not legal advice."}