Kunshan Jiehong Nonwoven Product Co., Ltd.
Registered establishment in Kunshan, Jiangsu, China. 12 device types, 2 clearances.
Kunshan Jiehong Nonwoven Product Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 10 other device types. Its earliest product listing with the FDA dates from 2009.
12device types registered with the FDA
2510(k) clearances
Registration
| Registered name | KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006437555 |
| FEI number | 3006437555 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | No.895 Xinle Road |
| Postal code | 215345 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 2010 | 439 | |
| Bedding, Disposable, Medical | Class 1 | 2012 | 308 | |
| Cap, Surgical | Class 1 | 2009 | 178 | |
| Drape, Surgical, Antimicrobial | Class 2 | 2011 | 39 | |
| Drape, Surgical, Exempt | Class 2 | 2017 | 107 | |
| Dress, Surgical | Class 1 | Medical disposal protective clothing (coverall) | 2020 | 71 |
| Fiber, Medical, Absorbent | Class 1 | 2025 | 172 | |
| Gown, Surgical | Class 2 | 2011 | 68 | |
| Non-Surgical Gown | Class 1 | JIEHONG Non-surgerical isolation gown | 2011 | 318 |
| Operating Room Accessories Table Tray | Class 1 | 2012 | 25 | |
| Suit, Surgical | Class 1 | Coverall Surgical Suit | 2010 | 74 |
| Support, Patient Position | Class 1 | 2019 | 66 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K112136 | 2011-09-29 | KKX | Traditional | This company |
| K111067 | 2011-08-02 | FYA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Employees | 600 |
| Factory area | 20000 m² |
| Main products | Surgical gowns, Isolation gowns, Surgical drapes, Surgical caps |
| Certifications | ISO13485, CE |
Nearby Manufacturers
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.