Airgle
The FDA filing states its intended use applies to Airgle Room Air Purifier models AG300, AG600 and AG900. The free-standing purifier uses germicidal UV-C light near 254 nm to inactivate…
The FDA filing states its intended use applies to Airgle Room Air Purifier models AG300, AG600 and AG900.
The free-standing purifier uses germicidal UV-C light near 254 nm to inactivate indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces.
Listed Item
The Airgle Clean Room Air Purifier AG900 is a free-standing air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254 nm), intended for the inactivation of indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to be effective against MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure and operating conditions: Test Item(s): MS2 Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes
Air Treatment
Its housing contains carbon and cHEPA filters and a Titanium Pro UV-C module.
The filing describes air moving through the purifier housing.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Airgle Corporation, United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232645 |
| Record published | 2025-05-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG900 | In distribution | |
| AF600HC | In distribution | |
| AF300HCT | In distribution | |
| AG300 | In distribution | |
| AG600 | In distribution | |
| AF600T | In distribution | |
| AG930 | In distribution | |
| AF900T | In distribution | |
| AG700 | In distribution | |
| AF900HC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RGF-BioControls | RGF Environmental Group, Inc | 9 |
| Aerobiotix | Aerobiotix USA | 5 |
| ADS | Guangzhou Ajax Medical Equipment Co Ltd | 5 |
| Molekule Air Mini + | Molekule Group, Inc. | 2 |
| Molekule | Molekule Group, Inc. | 1 |
| The Pyure Company | The Pyure Company Inc | 1 |
| ActivePure Medical Guardian | Activepure Medical LLC | 1 |
| Purgo | Molekule Group, Inc. | 1 |
| RGS mini | Genesis AIR, Inc. | 1 |
| Medical Guardian | Aerus Medical, LLC | 1 |
| RGS | Genesis AIR, Inc. | 1 |
| Molekule Air Pro | Molekule Group, Inc. | 1 |
Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232645 | 2024-02-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.