21 CFR § 868.5560 - Gas mask head strap.
§ 868.5560 Gas mask head strap.
(a) Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.
(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.