Data / Medical devices / Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (NZJ): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (product code NZJ, Class 2, 21 CFR 880.6260). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on January 23, 2009, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NZJ
- Device class
- 2
- Regulation
- 880.6260
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 1 |
| South Korea | 1 |
| Singapore | 1 |
| Vietnam | 1 |
Makers of Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3M Company | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 1 | May 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Hydrochem Co., Ltd | Gangeung-Si Gangwon, South Korea | Manufacturer | 1 | May 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Pasture Pharma Pte Ltd | Corporation Place Central Singapore, Singapore | Exporter to the US, Manufacturer | 1 | January 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| An Lanh Investment And Trading Company Limited | Thanh Nam Ward Ninh Binh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengde Technology Co., Ltd | Longgang Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mondial Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Sanshan Optics Co., Ltd. | WENZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Zhongyi Safety & Protection Products Co.,Ltd. | Xiantao City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 23, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.