Xiantao Zhongyi Safety & Protection Products Co., Ltd.
Registered establishment in Xiantao, Hubei, China. 10 device types, 1 clearance.
Xiantao Zhongyi Safety & Protection Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 8 other device types. Its earliest product listing with the FDA dates from 2012.
10device types registered with the FDA
1510(k) clearance
Registration
| Registered name | Xiantao Zhongyi Safety & Protection Products Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010141571 |
| FEI number | 3010141571 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 仙桃市中意安全防护用品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | No.101, Xianyuan Road |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Zhongyi | 2012 | 439 |
| Cap, Surgical | Class 1 | Zhongyi | 2012 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Zhongyi | 2012 | 176 |
| Gown, Examination | Class 1 | Zhongyi | 2012 | 109 |
| Mask, Scavenging | Class 1 | Zhongyi | 2012 | 158 |
| Mask, Surgical | Class 2 | 2021 | 125 | |
| Non-Surgical Gown | Class 1 | Zhongyi | 2012 | 318 |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | Class 2 | NIOSH N95 MASK, Model ZYB-11, ZYB-12, ZYB-13,ZYB-14 ,ZYE-02 ,ZYE-05 | 2022 | 4 |
| Respirator, Surgical | Class 2 | Zhongyi Surgical N95 Air-purifying Flitering Facepiece Respirator (mode# ZY9501S,ZY9503S) | 2024 | 118 |
| Suit, Surgical | Class 1 | Zhongyi | 2012 | 74 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203685 | 2021-03-26 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | disposable dust masks, respirators, surgical face masks, protective equipment |
| Certifications | ISO, NIOSH |
Nearby Manufacturers
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.
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