Surgical Face Mask
These surgical face masks are disposable barriers intended to reduce transfer of microorganisms, body fluids and particulate material between patients and healthcare personnel. They are…
These surgical face masks are disposable barriers intended to reduce transfer of microorganisms, body fluids and particulate material between patients and healthcare personnel. They are provided nonsterile for single use in infection control practices.
The mask has polypropylene nonwoven inner and outer layers surrounding a meltblown polypropylene middle layer. The latex free family includes tie strap and elastic ear loop configurations, with attachment type varying by model.
Barrier Levels
The 522 series models meet ASTM F2100 Level 2 requirements, including synthetic blood penetration resistance at 120 mmHg. The 533 series meets Level 3 at 160 mmHg. Both series specify bacterial and submicron particle filtration efficiency of at least 98%.
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 | Foshan Nanhai Plus Medical Co Ltd, China |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K212610 |
| Record published | 2022-02-21 |
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 | Pack of 50, pack of 30, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 533-002 | In distribution | |
| 522-003 | In distribution | |
| 533-005 | In distribution | |
| 533-006 | In distribution | |
| 522-006 | In distribution | |
| 522-001 | In distribution | |
| 522-005 | In distribution | |
| 533-003 | In distribution | |
| 522-004 | In distribution | |
| 533-001 | In distribution | |
| 533-004 | In distribution | |
| 522-002 | 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 |
| AOK | AOK Tooling Limited | 31 |
Showing 12 of 415. All products under Mask, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212610 | 2022-01-26 |
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.