Data / Medical devices / China / Xiantao Dingcheng Nonwoven Products Co., Ltd.
Xiantao Dingcheng Nonwoven Products Co., Ltd.: FDA-registered device maker in Xiantao Hubei, China, 2 510(k) clearances
Xiantao Dingcheng Nonwoven Products Co., Ltd. is registered with the FDA (registration 3010154727) in Xiantao Hubei, China. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 12, 2022. Registered through 2026. FDA data exported November 2, 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
- 3010154727
- Address
- Liukou Industrial Park, Xiantao Hubei, China, 433000
- Owner or operator
- Xiantao Dingcheng Nonwoven Products Co., Ltd. (10049089)
- Roles
- Manufacturer
- First device listed
- April 11, 2015
- Registered through
- 2026
- Brand names listed
- Bed sheet, Bed cover, Pillowcase cover, Drape surgical exempt, bouffant cap; surgical cap; Clip cap; Nonwoven Cap, coverall; Nonwoven Face Mask, isolation gown; lab coat, shoe cover, surgical apparel, gown, surgical mask
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 |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 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 |
|---|---|---|---|---|---|---|
| January 12, 2022 | K212718 | Surgical gowns | FYA | Substantially Equivalent | Xiantao Dingcheng Non-Woven Product Co., Ltd. | accessdata.fda.gov |
| November 16, 2021 | K212344 | Surgical Mask | FXX | Substantially Equivalent | Xiantao Dingcheng Non-Woven Product Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Shoe, Operating-Room
- All makers of Accessory, Surgical Apparel
- All makers of Drape, Surgical, Exempt
- All makers of Gown, Surgical
- All makers of Mask, Surgical
- All makers of Cap, Surgical
Updated January 12, 2022. 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.