Premier Medical Gloves Factory
ChinaFDA applicant, unverified FDA FEI 3009118264
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Premier Medical Gloves Factory makes
Premier Medical Gloves Factory manufactures synthetic vinyl examination gloves, including powder-free variants and multiple label options. These gloves are designed for single-use medical and clinical procedures to maintain hygiene and reduce contamination risk.
The company’s products are classified under FDA’s Class I medical devices and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009118264
- Address
- No. 8-2, Xingan Rd.,Dongcheng, Linqu, Weifang Shandong
Frequently asked questions
How many devices does Premier Medical Gloves Factory have in the registry?
The registry currently lists 1 device for Premier Medical Gloves Factory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Premier Medical Gloves Factory's devices?
Among its 1 most recently registered device, Premier Medical Gloves Factory has devices listed in FDA 510(k) (1 device).
What risk classes do Premier Medical Gloves Factory's devices fall under?
Among its 1 most recently registered device, the classes recorded for Premier Medical Gloves Factory's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Premier Medical Gloves Factory in the registry?
The most recently registered devices listed for Premier Medical Gloves Factory include SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS).