Halyard
HALYARD* FLUIDSHIELD* Level 1 Surgical Mask with SO SOFT* Lining and Horizontal Ties-Wraparound Visor with Anti-Glare
125manufacturers in China registered for this device type
103catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | FXX |
| Device type | Mask, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211066 |
| Record published | 2019-05-13 |
| Record revised | 2023-08-30 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 6, case of 10, case of 4, pack of 6, case of 12 |
| Distribution end date | 2024-03-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47567 | 50 | In distribution | |
| 49235 | 50 | In distribution | |
| 37525 | 50 | In distribution | |
| 00152 | 50 | In distribution | |
| 47298 | 25 | In distribution | |
| 49310 | 50 | In distribution | |
| 00148 | 40 | In distribution | |
| 39124 | 25 | In distribution | |
| 39118 | 25 | In distribution | |
| 49240 | 50 | In distribution | |
| 62363 | 50 | In distribution | |
| 47573 | 50 | In distribution | |
| 47572 | 50 | In distribution | |
| 49242 | 50 | In distribution | |
| 62115 | 50 | In distribution | |
| 62354 | 50 | In distribution | |
| 25867 | 50 | In distribution | |
| 48220 | 50 | In distribution | |
| 49215 | 50 | In distribution | |
| 47578 | 50 | In distribution | |
| 48208 | 50 | In distribution | |
| 62356 | 50 | In distribution | |
| 62116 | 25 | In distribution | |
| 47717 | 50 | In distribution | |
| 47569 | 50 | In distribution | |
| 28804 | 25 | In distribution | |
| 49514 | 50 | In distribution | |
| 48207 | 50 | In distribution | |
| 48100 | 50 | In distribution | |
| 59928 | 50 | In distribution | |
| 47650 | 35 | In distribution | |
| 47700 | 50 | In distribution | |
| 25868 | 50 | In distribution | |
| 47574 | 50 | In distribution | |
| 49214 | 50 | In distribution | |
| 49521 | 50 | In distribution | |
| 62408 | 50 | In distribution | |
| 41802 | 50 | In distribution | |
| 00146 | 25 | In distribution | |
| 47575 | 50 | In distribution | |
| 41798 | 25 | In distribution | |
| 28802 | 50 | In distribution | |
| 49216 | 50 | In distribution | |
| 47576 | 50 | In distribution | |
| 47107 | 40 | In distribution | |
| 49325 | 50 | In distribution | |
| 49326 | 50 | In distribution | |
| 48297 | 50 | In distribution | |
| 39123 | 50 | In distribution | |
| 48388 | 50 | In distribution | |
| 47117 | 50 | In distribution | |
| 48237 | 25 | In distribution | |
| 48390 | 50 | In distribution | |
| 48247 | 25 | In distribution | |
| 47500 | 50 | In distribution | |
| 28806 | 50 | In distribution | |
| 47577 | 50 | In distribution | |
| 28797 | 40 | In distribution | |
| 47147 | 25 | In distribution | |
| 62114 | 25 | In distribution | |
| 28800 | 25 | In distribution | |
| 47080 | 50 | In distribution | |
| 47568 | 50 | In distribution | |
| 41805 | 50 | In distribution | |
| 47566 | 50 | In distribution | |
| 57578 | 50 | In distribution | |
| 47570 | 50 | In distribution | |
| 47137 | 25 | In distribution | |
| 25869 | 50 | In distribution | |
| 47571 | 50 | In distribution | |
| 41803 | 25 | In distribution | |
| 62484 | 300 | In distribution | |
| 49513 | 50 | In distribution | |
| 62113 | 50 | In distribution | |
| 47295 | 50 | In distribution | |
| 48296 | 50 | In distribution | |
| 48201 | 50 | Withdrawn | |
| 48248 | 25 | Withdrawn | |
| 48210 | 50 | Withdrawn | |
| 47090 | 50 | Withdrawn | |
| 47297 | 40 | Withdrawn | |
| 49700 | 50 | Withdrawn | |
| 39125 | 50 | Withdrawn | |
| 62367 | 50 | Withdrawn | |
| 47081 | 50 | Withdrawn | |
| 39117 | 50 | Withdrawn | |
| 41799 | 25 | Withdrawn | |
| 62357 | 50 | Withdrawn | |
| 49701 | 50 | Withdrawn | |
| 47085 | 50 | Withdrawn | |
| 28809 | 25 | Withdrawn | |
| 28808 | 50 | Withdrawn | |
| 28820 | 50 | Withdrawn | |
| 62362 | 50 | Withdrawn | |
| 47149 | 25 | Withdrawn | |
| 48105 | 50 | Withdrawn | |
| 47119 | 50 | Withdrawn | |
| 47625 | 35 | Withdrawn | |
| 62360 | 20 | Withdrawn | |
| 47116 | 50 | Withdrawn | |
| 28810 | 50 | Withdrawn | |
| 47095 | 50 | Withdrawn | |
| 28821 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Primed | Primed Medical Products Inc. | 119 |
| 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 |
| Monoart | Euronda SPA | 31 |
Showing 12 of 415. All products under Mask, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251967 | 2026-03-18 |
| K252941 | 2025-12-11 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| O&M Halyard, Inc. | 510(k) number | 2024-11-08 | Class II | Nonconforming Material/Component | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is r | 211 cases |
| O&M Halyard, Inc. | 510(k) number | 2024-11-08 | Class II | Nonconforming Material/Component | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is r | 637 cases |
| Owens & Minor Distribution, Inc. | UDI-DI | 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.