Data / Medical devices / China / XIANTAO XINFA PLASTIC PRODUCTS Co. LTD.
XIANTAO XINFA PLASTIC PRODUCTS Co. LTD.: FDA-registered device maker in Xiantao City Hubei, China, 1 510(k) clearance
XIANTAO XINFA PLASTIC PRODUCTS Co. LTD. is registered with the FDA (registration 3006538071) in Xiantao City Hubei, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006538071
- Address
- Zhongling Industrial Park Pengchang Town, Xiantao City Hubei, China, 433018
- Owner or operator
- XIANTAO XINFA PLASTIC CO., LTD. (9100065)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer
- First device listed
- April 6, 2007
- Registered through
- 2026
- Brand names listed
- Cap, Surgical
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Foreign private label distributor, 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 31, 2017 | K160471 | Medline Non-Surgical Isolation Gown- | FYC | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Examination
- All makers of Bedding, Disposable, Medical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
- All makers of Cover, Shoe, Operating-Room
- All makers of Gown, Isolation, Surgical
Updated January 31, 2017. 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.