Medline
MASK,RESPIRATOR,N95,NIOSH Approved,lf
118manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MSH |
| Device type | Respirator, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K092824 |
| Record published | 2024-03-27 |
| Record revised | 2023-09-13 (version 7) |
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 |
| Storage | Special storage condition: Keep Dry. Avoid excessive heat – protect from freezing. |
| Packaging | Pack of 6, case of 6, pack of 24, pack of 4, box of 20, case of 240 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NON26595 | 50 | In distribution | |
| MEDN95 | 2 | In distribution | |
| NON27381 | 50 | In distribution | |
| NON27501 | In distribution | ||
| MED381 | 10 | In distribution | |
| NON24506A | In distribution | ||
| NON24507A | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Defend | Young Mydent, LLC | 43 |
| Halyard | O&M Halyard, Inc. | 17 |
| GPS | Group Practice Solutions | 10 |
| Moldex | Moldex/Metric, Inc. | 10 |
| 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
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.