Monoart
Disposable, hypo-allergenic face mask with 4 layers: a soft water-repellent non-woven fabric for unparalleled protection from dust and moisture; PFE and BFE (Particle Filtration Efficiency…
Disposable, hypo-allergenic face mask with 4 layers: a soft water-repellent non-woven fabric for unparalleled protection from dust and moisture; PFE and BFE (Particle Filtration Efficiency and Bacterial Filtration Efficiency) filter; a polymeric filter for excellent fluid resistance, 120 mmHg; a comfortable absorbent hypoallergenic cellulose layer in contact with the skin, for effective absorption of sweat and humidity when used by operators. Built-in nose bridge Made with selected hypo-allergenic materials which have been carefully sourced to respect sensitive skins and avoid the risk of irritation and dermatitis. Box of 50 masks. Colour: Light blue.
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 | Euronda SPA, Italy |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Private-label distributor, Manufacturer |
| Record published | 2019-11-28 |
| Record revised | 2025-04-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Carton of 20, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 4 Sensitive | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection Soft | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection Graffiti | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection Graffiti | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection Graffiti | In distribution | |
| Monoart Face Mask Protection 4 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection Graffiti | In distribution | |
| Monoart Face Mask Protection 3 | In distribution | |
| Monoart Face Mask Protection 3 | 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
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.