21 CFR 868.5570
§ 868.5570 Nonrebreathing mask.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5570, § 868.5570 Nonrebreathing mask, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89813
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ys:prov:89813@1- SHA-256
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Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.