Data / Medical devices / China / Allmed Medical (hubei) Protective Products Co., Ltd
Allmed Medical (hubei) Protective Products Co., Ltd: FDA-registered device maker in Zhijiang Hubei, China, 2 510(k) clearances
Allmed Medical (hubei) Protective Products Co., Ltd is registered with the FDA (registration 3021274073) in Zhijiang Hubei, China. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021274073
- Address
- No.29 Dong Hu Road, Majiadian Town, Zhijiang Hubei, China, 443200
- Owner or operator
- Allmed Medical (Hubei) Protective Products Co., Ltd (10083310)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 10, 2021
- Registered through
- 2026
- Brand names listed
- Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)), NA, None, Surgical gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| September 29, 2022 | K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | FYA | Substantially Equivalent | Allmed Medical (Hubei) Protective Products Co., Ltd. | accessdata.fda.gov |
| August 12, 2022 | K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | FYC | Substantially Equivalent | Allmed Medical (Hubei) Protective Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cap, Surgical
- All makers of Drape, Surgical, Exempt
- All makers of Mask, Surgical
- All makers of Cover, Shoe, Operating-Room
- All makers of Gown, Surgical
- All makers of Non-Surgical Gown
Updated September 29, 2022. 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.