Kunshan Jiehong Nonwoven Product Co., Ltd.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Kunshan Jiehong Nonwoven Product Co., Ltd. makes
The company manufactures sterile and non-sterile surgical drapes, including top drapes and bottom drapes, as well as sterile and non-sterile surgical gowns. These products are designed for use in medical and surgical settings to maintain sterile fields and protect personnel and patients during procedures.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, adhering to U.S. regulatory standards for surgical textiles and protective apparel.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Jie+hong Medical Surgical Gowns - Sterile, Jie+hong Medical Surgical Gowns - Non Sterile Ref K111067
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Kunshan Jiehong Nonwoven Product Co., Ltd. KUNSHAN CITY Jiangsu · CN FEI 3006437555
Frequently asked questions
How many devices does Kunshan Jiehong Nonwoven Product Co., Ltd. have in the registry?
The registry currently lists 2 devices for Kunshan Jiehong Nonwoven Product Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kunshan Jiehong Nonwoven Product Co., Ltd.'s devices?
Among its 2 most recently registered devices, Kunshan Jiehong Nonwoven Product Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Kunshan Jiehong Nonwoven Product Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kunshan Jiehong Nonwoven Product Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kunshan Jiehong Nonwoven Product Co., Ltd. in the registry?
The most recently registered devices listed for Kunshan Jiehong Nonwoven Product Co., Ltd. include TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE and JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE.
Which FDA establishments are linked to Kunshan Jiehong Nonwoven Product Co., Ltd.?
1 FDA establishment is linked to Kunshan Jiehong Nonwoven Product Co., Ltd. in the registry; they are listed on the company page.