Written and maintained by CASRAI Editorial Board
Last updated
General information only, not medical advice. This guide describes oxygen mask types as devices. It does not tell any person which mask to use; that is a clinician’s decision.
Overview
An oxygen face mask is, in the words of the U.S. Code of Federal Regulations, “a device placed over a patient’s nose, mouth, or tracheostomy to administer oxygen or aerosols” (21 CFR 868.5580, checked 2026-11-01). The common types differ in how closely the delivered oxygen fraction (FiO2) is fixed and how high it can go: simple masks, Venturi masks (a predetermined concentration) and non-rebreather reservoir masks (the usual answer to “high oxygen concentration mask”). The table below pairs each type with a published FiO2 range and its U.S. FDA regulatory identity.
This page covers oxygen therapy masks. CPAP masks, respirators (“gas masks”) and cosmetic skincare masks are different products; see CPAP and oxygen mask types and the section on lookalikes below.
Types of oxygen face masks compared
| Type | What it is | Published FiO2 range | FDA identity (checked 2026-11-01) | Notes from sources |
|---|---|---|---|---|
| Oxygen mask (general term) | Device placed over the nose, mouth or tracheostomy to administer oxygen or aerosols | Depends on the specific type | 21 CFR 868.5580; product code BYG, “Mask, Oxygen”; Class I, exempt from 510(k) subject to 868.9 | Definition only; no performance range in the regulation |
| Simple face mask | Face mask supplying oxygen from a source | FiO2 0.35-0.60 | Covered under the general oxygen mask regulation (21 CFR 868.5580) | Delivered FiO2 varies between patients |
| Venturi mask | Contains an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration | FiO2 0.24-0.60 | 21 CFR 868.5600; product code BYF, “Mask, Oxygen, Low Concentration, Venturi”; Class I, 510(k)-exempt subject to 868.9 | Designed to deliver a predetermined concentration |
| Non-rebreather mask with reservoir | Fits over the face; one-way valves prevent rebreathing of previously exhaled gases | FiO2 above 0.60 (100% non-rebreather reservoir mask) | 21 CFR 868.5570; product code KGB, “Mask, Oxygen, Non-Rebreathing”; Class I, 510(k)-exempt subject to 868.9 | Delivered FiO2 varies between patients |
Source for the FiO2 figures: Thoracic Society of Australia and New Zealand (TSANZ) guideline, Respirology 2015;20(8):1182-1191 (PMC4654337), checked 2026-11-01. The guideline notes that actual delivered FiO2 varies between patients, for example with breathing rate and whether the mouth is open, so the ranges are approximate values, not guarantees. For comparison, the same source gives standard nasal cannulae as FiO2 0.24-0.35.
High oxygen concentration mask
Among the masks above, the 100% non-rebreather reservoir mask is the type the guideline lists as able to deliver an FiO2 above 0.60. Read the device-level detail in what a non-rebreather mask is.
Low and fixed concentration masks
A simple face mask covers the 0.35-0.60 range, and a Venturi mask is the type defined by a predetermined concentration. See simple face mask flow rates and the Venturi mask guide for each device. Aerosol delivery through a mask is covered in the aerosol mask guide.
What the regulation and the product record let you check
- Which regulatory description fits. A non-rebreathing mask is defined by one-way valves that prevent rebreathing; a Venturi mask is defined by its air-oxygen mixing mechanism. A product described as either should have that feature.
- Product code and class. The FDA classification database lists BYG, BYF and KGB, all Class I. Class I devices under these sections are exempt from premarket notification (510(k)) subject to the limitations in 21 CFR 868.9.
- The manufacturer’s instructions for use. Concentration claims for a specific product belong in its own instructions; the figures in the table are guideline values for each type, not product specifications.
Masks that are not oxygen therapy masks
- CPAP masks deliver pressurised air from a machine; see CPAP and oxygen mask types.
- “Gas mask with oxygen” is usually a respirator question; see gas mask types. Respirators filter or supply air for the wearer and are a separate topic from oxygen therapy.
- Cosmetic “oxygenating” face masks are skincare products and are outside this guide, which covers devices defined in 21 CFR 868.5580 and related sections.
FAQ
What are the types of oxygen face masks?
The main types in the guideline are the simple face mask, the Venturi mask and the non-rebreather reservoir mask, with nasal cannulae as the lower-concentration alternative. The FDA groups the masks under oxygen mask (21 CFR 868.5580), Venturi (868.5600) and non-rebreathing (868.5570).
What is a high oxygen concentration mask?
A 100% non-rebreather reservoir mask, which the TSANZ guideline says can deliver an FiO2 above 0.60.
Is a gas mask the same as an oxygen mask?
No. A gas mask is a respirator, a different device category from the oxygen masks regulated under 21 CFR 868.5580. See the gas mask types guide.
Do oxygen masks need FDA clearance?
The three regulations above classify these masks as Class I (general controls) and exempt from 510(k) subject to the limitations in 21 CFR 868.9.
Where can I read about related respiratory equipment?
See the respiratory therapy equipment overview and the nasal cannula guide.
Sources
- 21 CFR 868.5580, Oxygen mask, Cornell LII, https://www.law.cornell.edu/cfr/text/21/868.5580 (checked 2026-11-01)
- 21 CFR 868.5570, Nonrebreathing mask, https://www.law.cornell.edu/cfr/text/21/868.5570 (checked 2026-11-01)
- 21 CFR 868.5600, Venturi mask, https://www.law.cornell.edu/cfr/text/21/868.5600 (checked 2026-11-01)
- FDA device classification database via openFDA, product codes BYG, BYF, KGB, https://api.fda.gov/device/classification.json (checked 2026-11-01)
- TSANZ acute oxygen use guideline, Respirology 2015;20(8):1182-1191, https://pmc.ncbi.nlm.nih.gov/articles/PMC4654337/ (checked 2026-11-01)
