Scpc
The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer…
The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The surgical masks is held over the user’s mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
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 | Sichuan Pharmaceutical., Inc., China |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K210813 |
| Record published | 2021-12-01 |
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 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ear Loops, Flat Pleated, 3 layers | 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 |
|---|---|
| K210813 | 2021-10-08 |
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.