Data / Medical devices / China / Hubei Xinxin Non-Woven Co., Ltd
Hubei Xinxin Non-Woven Co., Ltd: FDA-registered device maker in Xiantao Hubei, China, 6 510(k) clearances
Hubei Xinxin Non-Woven Co., Ltd is registered with the FDA (registration 3011547453) in Xiantao Hubei, China. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 20, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011547453
- Address
- Taizihu Industrial Park, Pengchang Town, Xiantao Hubei, China, 433018
- Owner or operator
- Hubei Xinxin Non-woven Co., Ltd (10048894)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 17, 2015
- Registered through
- 2026
- Brand names listed
- AAMI 3 isolation Gown
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 |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | 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 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 20, 2026 | K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | FYA | Substantially Equivalent | Hubei Xinxin Non-Woven Co., Ltd. | accessdata.fda.gov |
| May 16, 2024 | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | FYC | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| January 28, 2022 | K212120 | Surgical Masks | FXX | Substantially Equivalent | Hubei Xinxin Non-Woven Co., Ltd. | accessdata.fda.gov |
| April 26, 2019 | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | QPC | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| March 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| June 11, 1984 | K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
- All makers of Cover, Shoe, Operating-Room
- All makers of Cap, Surgical
Updated April 20, 2026. 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.