Data / Medical devices / China / Kunshan Jiehong Nonwoven Product Co., Ltd.
Kunshan Jiehong Nonwoven Product Co., Ltd.: FDA-registered device maker in KUNSHAN CITY Jiangsu, China, 2 510(k) clearances
Kunshan Jiehong Nonwoven Product Co., Ltd. is registered with the FDA (registration 3006437555) in KUNSHAN CITY Jiangsu, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2011. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006437555
- Address
- No.895 Xinle Road Dianshanhu Town, KUNSHAN CITY Jiangsu, China, 215345
- Owner or operator
- KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. (9094909)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 31, 2009
- Registered through
- 2026
- Brand names listed
- Coverall Surgical Suit, JIEHONG Non-surgerical isolation gown, Medical disposal protective clothing (coverall)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract 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, 2011 | K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | KKX | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
| August 2, 2011 | K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE | FYA | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Antimicrobial
- All makers of Gown, Surgical
- All makers of Operating Room Accessories Table Tray
- All makers of Fiber, Medical, Absorbent
- All makers of Cap, Surgical
- All makers of Dress, Surgical
Updated September 29, 2011. 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.