ProGear/Oxafence
Antiviral Earloop Mask, ASTM Level 3
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| Listed by | Prestige Ameritech, United States |
|---|---|
| FDA product code | OUK |
| Device type | Surgical Mask With Antimicrobial/Antiviral Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2025-08-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Amazon case of 30, case of 10, case of 62 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AV82030-30 | In distribution | ||
| AV82030 | 50 | In distribution | |
| AV82030-12 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RespoKare | Innonix Technologies Limited | 5 |
| Medline | Medline Industries, Inc. | 1 |
| Meijer | Meijer, Inc. | 1 |
| Curad | Medline Industries, Inc. | 1 |
| Cufitec Surgical Mask | Nbc Meshtec, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231741 | 2024-09-05 |
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.