Shandong Huayue Glove Co., Ltd.
Registered establishment in Zibo, Shandong, China. 3 device types, 2 clearances.
Shandong Huayue Glove Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Latex Patient Examination Glove, Vinyl Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | SHANDONG HUAYUE GLOVE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007707004 |
| FEI number | 3007707004 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | East of Yifan Rd. and North of Naqi Rd. |
| Postal code | 255400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Latex Patient Examination Glove | Class 1 | 2023 | 12 | |
| Polymer Patient Examination Glove | Class 1 | Huayue | 2019 | 83 |
| Vinyl Patient Examination Glove | Class 1 | 2009 | 72 |
Clearances
2 clearances name Shandong Huayue Glove Co., Ltd. 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 |
|---|---|---|---|---|
| K090520 | 2009-05-18 | LYZ | Traditional | This company |
| K090513 | 2009-05-08 | LYZ | Traditional | This company |
| K222074 | 2022-10-17 | LZA | Traditional | Zibo Langu New Material Technology Co., Ltd. |
| K170393 | 2017-05-09 | LZA | Traditional | Zibo Chengxun Automatic Device 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.