RiskWise Health Kits
A convenience kit containing multiple legally marketed medical devices and over the counter drug products packaged together for consumer use, including respiratory protective equipment,…
A convenience kit containing multiple legally marketed medical devices and over the counter drug products packaged together for consumer use, including respiratory protective equipment, temperature monitoring devices, and a diagnostic test, intended for general health preparedness and monitoring.
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 | Riskwise Supplies LLC, United States |
|---|---|
| FDA product code | MSH |
| Device type | Respirator, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-18 |
| Record revised | 2026-06-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSTK-IND | Withdrawn |
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 |
| 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 |
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.