Data / Medical devices / China / Hubei Huanfu Plastic Products Co., Ltd
Hubei Huanfu Plastic Products Co., Ltd: FDA-registered device maker in HANCHUAN CITY Hubei, China, 1 510(k) clearance
Hubei Huanfu Plastic Products Co., Ltd is registered with the FDA (registration 3004105221) in HANCHUAN CITY Hubei, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004105221
- Address
- No. 188 WANFU STREET, CHENHU TOWN, HANCHUAN CITY Hubei, China, 431608
- Owner or operator
- Hubei Huanfu Plastic Products Co., Ltd. (9057645)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 28, 2003
- Registered through
- 2026
- Brand names listed
- Burn Sheet, CONDUCTIVE#GENERAL AND PLASTIC SUR, SHOE COVER, GERY, Coverall, Disposable Bedding, EXAMINATION#GENERAL HOSPITAL, Expectant Father Kits, Face Mask, GOWN 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 | Contract manufacturer, 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 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 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 |
|---|---|---|---|---|---|---|
| November 14, 2021 | K212575 | Surgical Face Mask | FXX | Substantially Equivalent | Hubei Huanfu Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Protective, Personnel
- All makers of Gown, Examination
- All makers of Non-Surgical Gown
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Cover, Shoe, Operating-Room
- All makers of Sheet, Burn
Updated November 14, 2021. 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.