Halyard
FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Regular Size
118manufacturers in China registered for this device type
17catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (27), Guangdong (22), Zhejiang (21). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Vistar Medical Supplies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| AAB (China) Co., Ltd. | Nanan | Fujian | Contract manufacturer | 9 |
| Jiangsu Hongxin Medical Technology Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 7 |
| AOK Tooling Limited | Shen Zhen | Guangdong | Contract manufacturer | 6 |
| Coomex Sources Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
Showing 12 of 118. All 118 manufacturers in China registered for Respirator, Surgical
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | MSH |
| Device type | Respirator, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K974068 |
| Record published | 2016-04-28 |
| Record revised | 2023-09-13 (version 6) |
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 |
| Packaging | Case of 6, pack of 9, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 62355 | 50 | In distribution | |
| 76867 | 35 | In distribution | |
| 76827 | 35 | In distribution | |
| 46727 | 35 | In distribution | |
| 99181 | 100 | In distribution | |
| 46767 | 35 | In distribution | |
| 99184 | 100 | In distribution | |
| 46728 | 35 | In distribution | |
| 46867 | 35 | In distribution | |
| 46828 | 35 | In distribution | |
| 49300 | 15 | In distribution | |
| 99175 | 100 | In distribution | |
| 76727 | 35 | In distribution | |
| 76767 | 35 | In distribution | |
| 62126 | 50 | In distribution | |
| 46827 | 35 | In distribution | |
| 49299 | 15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Defend | Young Mydent, LLC | 43 |
| GPS | Group Practice Solutions | 10 |
| Moldex | Moldex/Metric, Inc. | 10 |
| Medline | Medline Industries, Inc. | 7 |
| Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | 7 |
| Perfetta Face Mask | PHU BAO Medical Co., Ltd. | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Perfetta Ultra Face Mask | PHU BAO Medical Co., Ltd. | 4 |
| Medicom Safemask | AMD Medicom Inc. | 4 |
| 3M™ Aura™ | 3M Company | 4 |
| WeCare | Jeg & Sons Inc. | 4 |
| Dukal | Dukal LLC | 3 |
Showing 12 of 88. All products under Respirator, Surgical
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 2023-08-09 | Class II | Under Investigation by firm | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. | 41790 masks |
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.