Henry Schein
MaxiGard Air Masks Sample pack - 1 mask blue, 1 mask white, 1 mask lavender + sample card
125manufacturers in China registered for this device type
77catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K133070 |
| Record published | 2016-09-24 |
| Record revised | 2023-09-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at cool dry place. Avoid excessive heat 40C or 104F |
| Packaging | Case of 6, case of 10, pack of 10, case of 20, pack of 4, pack of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1125576 | 50 | In distribution | |
| 1125575 | 50 | In distribution | |
| 9007453 | 50 | In distribution | |
| 1048073 | 50 | In distribution | |
| 5701525 | 50 | In distribution | |
| 5701529 | 50 | In distribution | |
| 5700722 | 50 | In distribution | |
| 5700159 | 50 | In distribution | |
| 9004210 | 50 | In distribution | |
| 5702443 | 50 | In distribution | |
| 5700590 | 5 | In distribution | |
| 5701526 | 50 | In distribution | |
| 5700722 | 50 | In distribution | |
| 5700723 | 50 | In distribution | |
| 5700738 | 50 | In distribution | |
| 5700724 | 50 | In distribution | |
| 5702268 | 50 | In distribution | |
| 9004210 | 50 | In distribution | |
| 1044632 | 50 | In distribution | |
| 1048600 | 50 | In distribution | |
| 5700716 | 50 | In distribution | |
| 1046611 | 50 | In distribution | |
| 5703114 | 25 | In distribution | |
| 1048072 | 50 | In distribution | |
| 5703113 | 25 | In distribution | |
| 1008350 | 50 | In distribution | |
| 5701529 | 50 | In distribution | |
| 5700724 | 50 | In distribution | |
| 1044632 | 50 | In distribution | |
| 5702451 | 50 | In distribution | |
| 5702044 | 50 | In distribution | |
| 5700738 | 50 | In distribution | |
| 1048600 | 50 | In distribution | |
| 5702448 | 50 | In distribution | |
| 5702452 | 50 | In distribution | |
| 9007452 | 50 | In distribution | |
| 1397703 | 50 | In distribution | |
| 1042849 | 50 | In distribution | |
| 1048071 | 50 | In distribution | |
| 1047321 | 25 | In distribution | |
| 1016829 | 50 | In distribution | |
| 1006723 | 100 | In distribution | |
| 5702043 | 50 | In distribution | |
| 5701525 | 50 | In distribution | |
| 5702453 | 50 | In distribution | |
| 5702829 | 50 | In distribution | |
| 1042849 | 50 | In distribution | |
| 1382800 | 50 | In distribution | |
| 5701527 | 50 | In distribution | |
| 1048819 | 50 | In distribution | |
| 5701527 | 50 | In distribution | |
| 1125577 | 50 | In distribution | |
| 1046611 | 50 | In distribution | |
| 5701528 | 50 | In distribution | |
| 9007454 | 50 | In distribution | |
| 5701526 | 50 | In distribution | |
| 1043809 | 50 | In distribution | |
| 1008356 | 50 | In distribution | |
| 5700739 | 50 | In distribution | |
| 5701530 | 50 | In distribution | |
| 1127252 | 50 | In distribution | |
| 5700739 | 50 | In distribution | |
| 1047799 | 50 | In distribution | |
| 1049200 | 50 | In distribution | |
| 5700823 | 3 | In distribution | |
| 5700723 | 50 | In distribution | |
| 1043730 | 50 | In distribution | |
| 1002686 | 100 | In distribution | |
| 1043730 | 50 | In distribution | |
| 5701530 | 50 | In distribution | |
| 5701528 | 50 | In distribution | |
| 9007451 | 50 | In distribution | |
| 5702450 | 50 | In distribution | |
| 5702449 | 50 | In distribution | |
| 5700159 | 50 | In distribution | |
| 1046809 | 50 | In distribution | |
| 1043809 | 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 |
| 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 |
| Monoart | Euronda SPA | 31 |
Showing 12 of 415. All products under Mask, Surgical
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| AMD Medicom Inc. | UDI-DI | 2023-12-21 | Class II | Under Investigation by firm | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. | 720 cases (10 boxes/case and 50 masks/box) |
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.