Shandong Kangli Medical Equipment Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3014666579
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shandong Kangli Medical Equipment Technology Co., Ltd. makes
Shandong Kangli Medical Equipment Technology Co., Ltd. manufactures surgical gowns, which are single-use protective garments designed for use in sterile surgical environments to prevent contamination of personnel and surgical sites.
The company’s surgical gowns are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Surgical Gown Ref K192560
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014666579
- Address
- Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Province, China, Zaozhuang Shandong
Frequently asked questions
How many devices does Shandong Kangli Medical Equipment Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Shandong Kangli Medical Equipment Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Kangli Medical Equipment Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Shandong Kangli Medical Equipment Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shandong Kangli Medical Equipment Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shandong Kangli Medical Equipment Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Kangli Medical Equipment Technology Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Kangli Medical Equipment Technology Co., Ltd. include Surgical Gown.