Shandong Huayue Glove Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3007707004
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shandong Huayue Glove Co., Ltd. makes
The company manufactures stretch vinyl examination gloves, specifically powder-free versions in yellow and white colors, designed for medical and clinical use.
These products fall under FDA Class I medical devices and are listed via the 510(k) pathway in the United States.
Catalogue
Vinyl Examination Glove Ref K090513
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007707004
- Address
- East of Yifan Rd. and North of Naqi Rd., Zibo Shandong
Frequently asked questions
How many devices does Shandong Huayue Glove Co., Ltd. have in the registry?
The registry currently lists 2 devices for Shandong Huayue Glove Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Huayue Glove Co., Ltd.'s devices?
Among its 2 most recently registered devices, Shandong Huayue Glove Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Shandong Huayue Glove Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Shandong Huayue Glove Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Huayue Glove Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Huayue Glove Co., Ltd. include VINYL EXAMINATION GLOVE and STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE).