AOK
The AOK 95A Medical Mask is a single-use, disposable face mask with ear loops or tie straps. The filing describes it as a four-layer folded mask that covers the nose and mouth. Its stated…
The AOK 95A Medical Mask is a single-use, disposable face mask with ear loops or tie straps. The filing describes it as a four-layer folded mask that covers the nose and mouth.
Its stated use is to provide a physical barrier against fluids and particulate material during infection-control practices. The filing names both patients and healthcare personnel in its intended population.
Listed Item
AOK 95A Medical Mask (20200049) (white)
Construction and Use
The mask includes a nose piece that can be shaped around the nose, and elastic ear loops that hold it over the mouth and nose. The filing says the device is supplied non-sterile.
Who Else Makes It
Concentrated in Hubei (38), Jiangsu (22), Zhejiang (13). 27 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| H&K International Trade Limited (China) | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| JM Medical Co., Ltd. | Liaocheng | Shandong | Contract manufacturer | 25 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Guangzhou Fuzelong Hygiene Material Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Hubei Weikang Protective Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 12 |
Showing 12 of 125. All 125 manufacturers in China registered for Mask, Surgical
Record
| Listed by | AOK Tooling Limited, China |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220876 |
| Record published | 2026-06-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 30, box of 40, box of 20, box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20200049-H-L | 30 | In distribution | |
| 20200049-M | 30 | In distribution | |
| 20200049-S | 30 | In distribution | |
| 20190039-013-XL | 20 | In distribution | |
| 20200049-H-S | 30 | In distribution | |
| 20190039-013-L | 20 | In distribution | |
| 20200049-H-M | 30 | In distribution | |
| 20190039-013-M | 20 | In distribution | |
| 20190039-013-S | 20 | In distribution | |
| 20190039-013-H-S | 20 | In distribution | |
| 20200049-S | 30 | In distribution | |
| 20190039-013-H-L | 20 | In distribution | |
| 20190039-013-H-M | 20 | In distribution | |
| 20190039-013-XL | 20 | In distribution | |
| 20190019 | 3 | In distribution | |
| 20200049-L | 30 | In distribution | |
| 20190039-013-H-S | 20 | In distribution | |
| 20190019 | 50 | In distribution | |
| 20200049-L | 30 | In distribution | |
| 20190039-013-S | 20 | In distribution | |
| 20200049-H-S | 30 | In distribution | |
| 20190039-013-H-XL | 20 | In distribution | |
| 20190039-013-L | 20 | In distribution | |
| 20190039-013-H-M | 20 | In distribution | |
| 20200049-M | 30 | In distribution | |
| 20190039-013-H-XL | 20 | In distribution | |
| 20200049-H-L | 30 | In distribution | |
| 20200049-H-M | 30 | In distribution | |
| 20190039-013-M | 20 | In distribution | |
| 20190019 | 5 | In distribution | |
| 20190039-013-H-L | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Primed | Primed Medical Products Inc. | 119 |
| Halyard | O&M Halyard, Inc. | 103 |
| Precept® | Precept Medical Products, Inc. | 77 |
| Henry Schein | Henry Schein, Inc. | 77 |
| Medline | Medline Industries, Inc. | 66 |
| Convertors | Cardinal Health 200, LLC | 51 |
| ProGear | Prestige Ameritech | 41 |
| Vivit Supply | Vivit Supply LLC | 38 |
| Critical Cover | Alpha Pro Tech, Inc. | 35 |
| JMU | JMU Dental, Inc | 34 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 31 |
| Monoart | Euronda SPA | 31 |
Showing 12 of 415. All products under Mask, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220876 | 2022-07-27 |
| K211956 | 2021-11-23 |
| K201517 | 2020-09-04 |
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.