Data / Medical devices / China / Xiantao Zhibo Nonwoven Products Co.,ltd
Xiantao Zhibo Nonwoven Products Co.,ltd: FDA-registered device maker in Xiantao City Hubei, China, 3 510(k) clearances
Xiantao Zhibo Nonwoven Products Co.,ltd is registered with the FDA (registration 3013580507) in Xiantao City Hubei, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 22, 2023. Registered through 2027. 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
- 3013580507
- Address
- No.8, Hefeng industrial zone, Pengchang Town, Xiantao City Hubei, China, 430000
- Owner or operator
- Xiantao Zhibo Nonwoven Products Co.,Ltd (10053753)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 7, 2017
- Registered through
- 2027
- Brand names listed
- Bed sheet, Pillow Cover, Cap, Disposable Medical Face Mask, Disposable Scrub, Gloves, Apron, Apparel, Isolation Gown, Protective clothing, coverall, medical, CPE gown, Scrub Suit, Mask, Mask, Surgical and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 22, 2023 | K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | FYA | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
| March 12, 2022 | K213806 | Disposable Medical Face Mask | FXX | Substantially Equivalent | Xiantao Zhibo Nonwoven Products Co., Ltd. | accessdata.fda.gov |
| January 24, 2019 | K182514 | Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Cover, Shoe, Operating-Room
- All makers of Suit, Surgical
- All makers of Gown, Surgical
- All makers of Non-Surgical Gown
- All makers of Cap, Surgical
Updated August 22, 2023. 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.