Data / Medical devices / China / Xiantao Zhongyi Safety & Protection Products Co.,Ltd.
Xiantao Zhongyi Safety & Protection Products Co.,Ltd.: FDA-registered device maker in Xiantao City Hubei, China, 1 510(k) clearance
Xiantao Zhongyi Safety & Protection Products Co.,Ltd. is registered with the FDA (registration 3010141571) in Xiantao City Hubei, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010141571
- Address
- No.101, Xianyuan Road, Xiantao City Hubei, China, 433000
- Owner or operator
- Xiantao Zhongyi Safety & Protecting Products Co.,Ltd (10042020)
- Roles
- Manufacturer
- First device listed
- October 9, 2012
- Registered through
- 2026
- Brand names listed
- NIOSH N95 MASK, Model ZYB-11, ZYB-12, ZYB-13,ZYB-14 ,ZYE-02 ,ZYE-05, ZHONGYI, Zhongyi Surgical N95 Air-purifying Flitering Facepiece Respirator (mode# ZY9501S,ZY9503S)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2021 | K203685 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Zhongyi Safety & Protection Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Cap, Surgical
- All makers of Cover, Shoe, Operating-Room
- All makers of Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- All makers of Suit, Surgical
- All makers of Mask, Scavenging
Updated March 26, 2021. 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.