Hubei Xinxin Non-woven Co., Ltd
Xiantao Hubei, CN
HUBEI XINXIN NON-WOVEN CO., LTD appears in FDA device records in Xiantao Hubei, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Hubei Xinxin Non-woven Co., Ltd between 2022 and 2026. The busiest year on record is 2022, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K214116 | AAMI4 Isolation Gown | FYC | Substantially Equivalent | |
| K213832 | AAMI3 Isolation Gown | FYC | Substantially Equivalent | |
| K212120 | Surgical Masks | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011547453 | 3011547453 | HUBEI XINXIN NON-WOVEN CO., LTD | Taizihu Industrial Park, Pengchang Town, Xiantao Hubei 433018 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- KMEBedding, Disposable, Medical
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- FYCGown, Isolation, Surgical
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- FYAGown, Surgical
- FXXMask, Surgical
- OEANon-Surgical Gown
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain