Medichoice
Mask Procedure Face PRIMAGARD160 Anti-Fog Foam Anti Glare Strip Stretchy Earloop With Anti Glare Visor Foam Strip Aluminum Nose Piece Indigo Disposable Not Made With Natural Rubber Latex…
Mask Procedure Face PRIMAGARD160 Anti-Fog Foam Anti Glare Strip Stretchy Earloop With Anti Glare Visor Foam Strip Aluminum Nose Piece Indigo Disposable Not Made With Natural Rubber Latex MediChoice
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 | Owens & Minor Distribution, Inc. |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Record published | 2016-08-20 |
| Record revised | 2020-07-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store in cool, dry, and well ventilated space out of direct sunlight |
| Packaging | Pack of 6, pack of 10, pack of 4, pack of 90 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PG4-1331 | 50 | In distribution | |
| PG4-6403 | 50 | In distribution | |
| PG4-2561 | 50 | In distribution | |
| PG4-4021 | 50 | In distribution | |
| PG4-4051 | 50 | In distribution | |
| PG4-2321 | 50 | In distribution | |
| PG4-2333 | 50 | In distribution | |
| PG4-1001 | 50 | In distribution | |
| PG4-2331 | 50 | In distribution | |
| PG4-2121 | 50 | In distribution | |
| PG4-2001 | 50 | In distribution | |
| PG4-2161 | 50 | In distribution | |
| PG4-4241 | 50 | In distribution | |
| PG4-5063 | 25 | In distribution | |
| PG4-1111 | 50 | In distribution | |
| PG4-1073 | 50 | In distribution | |
| PG4-3363 | 50 | In distribution | |
| PG4-5073 | 25 | In distribution | |
| PG4-5033 | 25 | In distribution | |
| PG4-2073 | 50 | In distribution | |
| PG4-1573 | 25 | In distribution | |
| PG4-4073 | 50 | In distribution | |
| PG4-1092 | 50 | In distribution | |
| PG4-1563 | 25 | In distribution | |
| PG4-1211 | 50 | In distribution | |
| PG4-4331 | 50 | 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
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-01-03 | Class III | Labeling Change Control | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops. | 73 cases |
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.