Premier Medical Gloves Factory
Registered establishment in Weifang, Shandong, China. 5 device types, 1 clearance.
Premier Medical Gloves Factory is a specification developer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Vinyl Patient Examination Glove and 3 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | PREMIER MEDICAL GLOVES FACTORY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009118264 |
| FEI number | 3009118264 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | No. 8-2, Xingan Rd.,Dongcheng, Linqu |
| Postal code | 262600 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | 2023 | 29 |
| Medical Glove, Specialty | Class 1 | 2023 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2023 | 32 |
| Polymer Patient Examination Glove | Class 1 | 2023 | 83 |
| Vinyl Patient Examination Glove | Class 1 | 2011 | 72 |
Clearances
1 clearance names Premier Medical Gloves Factory as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K111297 | 2011-06-16 | LYZ | Traditional | This company |
| K222815 | 2022-12-04 | LZA | Traditional | Zibo Lanhua Medical Packaging Material Co., Ltd. |
| K182640 | 2019-04-12 | LZA | Traditional | Shandong Hengya Packaging Printing Co., Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.