Data / Medical devices / China / Fomed Industries Inc
Fomed Industries Inc: FDA-registered device maker in Qian Jiang Hubei, China, 4 510(k) clearances
Fomed Industries Inc is registered with the FDA (registration 9680887) in Qian Jiang Hubei, China. It lists 19 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680887
- FEI number
- 3008439903
- Address
- 20 Han Sha Road Hou Hu District, Qian Jiang Hubei, China, 433115
- Owner or operator
- Fomed Industries Inc. (9010881)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 7, 2008
- Registered through
- 2026
- Brand names listed
- Air / Water Syringe Tips, Bandage, Elastic, Bandage, Elastic, Gauze packing, Triangular bandage, Bouffant caps, Cotton Tip Applicator, Micro Applicators, Cotton filled gauze pad, Cotton roll, Dental Barrier and Sleeves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| June 10, 2025 | K250735 | Dental Barrier and Sleeves | PEM | Substantially Equivalent | Fomed Industries, Inc. | accessdata.fda.gov |
| August 22, 2023 | K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | FYA | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
| April 25, 2022 | K220512 | Disposable Surgical Face Mask (M01, M02) | FXX | Substantially Equivalent | Fomed Industries, Inc. | accessdata.fda.gov |
| September 9, 2015 | K143637 | U&U Sterilization Pouch and Roll | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Cap, Surgical
- All makers of Dental Barriers And Sleeves
- All makers of Shoe And Shoe Cover, Conductive
- All makers of Suit, Surgical
- All makers of Bandage, Elastic
Updated June 10, 2025. 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.