Fomed Industries Inc
Manufacturer and brand owner in Qian Jiang, Hubei, China. 19 device types, 1 product catalogued, 2 clearances.
Fomed Industries Inc is a contract manufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Cap, Surgical and 17 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 9680887 |
| FEI number | 3008439903 |
| DUNS | 653922539 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖北福好医疗用品有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Qian Jiang |
|---|---|
| Province | Hubei |
| Address | 20 Han Sha Road |
| Postal code | 433115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Retractor, Dental | Class 1 | Air / Water Syringe Tips | 2024 | 37 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Tip Applicator, Micro Applicators | 2012 | 186 |
| Applicator, Resin | Class 1 | Mixing Bowl | 2024 | 24 |
| Bandage, Elastic | Class 1 | Bandage, Elastic, Gauze packing, Triangular bandage, Bandage, Elastic | 2012 | 280 |
| Cap, Surgical | Class 1 | Bouffant caps | 2024 | 178 |
| Cotton, Roll | Class 1 | Cotton roll | 2012 | 107 |
| Dental Barriers And Sleeves | Class 2 | Dental Barrier and Sleeves | 2025 | 12 |
| Fiber, Medical, Absorbent | Class 1 | absorbent medical fiber | 2012 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Cotton filled gauze pad, NON-STERILE GUAZE SPONGE, Non Woven Sponges, ABD Pads, Tracheotomy sponges, IV Drain sponges, Cotton filled sponges, | 2008 | 266 |
| Gown, Surgical | Class 2 | Surgical Gown (S, M, L, XL, XXL, XXXL); Reinforced Surgical Gown (S, M, L, XL, XXL, XXXL) | 2024 | 68 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | U&U Sterilization Pouch And Roll, SMMS wrap,CSR wrap | 2018 | 19 |
| Mask, Scavenging | Class 1 | Face Mask | 2013 | 158 |
| Mask, Surgical | Class 2 | Surgical Face Mask | 2022 | 125 |
| Non-Surgical Gown | Class 1 | Gown | 2019 | 318 |
| Shoe And Shoe Cover, Conductive | Class 1 | Shoe covers | 2024 | 32 |
| Suit, Surgical | Class 1 | Lab Coats, Lab Jackets, Protection gowns | 2024 | 74 |
| Tray, Impression, Preformed | Class 1 | Tray,Impression,Preformed(Impression tray) | 2016 | 73 |
| Unit, Operative Dental, Accessories | Class 1 | Unit, Operative Dental, Accessories (Barrier Film), Half Chair Sleeves, Headrest covers Sleeves, Tray Sleeves | 2016 | 65 |
| Wrap, Sterilization | Class 2 | U&U Sterilization Pouch And Roll, SMMS wrap,CSR wrap | 2018 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Fomed | FRG | 1 |
Clearances
2 clearances name Fomed Industries Inc as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250735 | 2025-06-10 | PEM | Traditional | This company |
| K220512 | 2022-04-25 | FXX | Traditional | This company |
| K231510 | 2023-08-22 | FYA | Traditional | Xiantao Zhibo Non-Woven Products Co., Ltd. |
| K143637 | 2015-09-09 | FRG | Traditional | U&U Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Factory area | 58000 m² |
| Main products | Sterilization pouches, Infection control supplies, Wound care products, Dental disposables, Medical gauze |
| Certifications | ISO13485, FDA, TUV |
| Export markets | Europe, North America, Japan, South Korea, Middle East, Southeast Asia |
| OEM and ODM | Offered |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.