True Glove Factory
Registered establishment in Weifang, Shandong, China. 4 device types, 2 clearances.
True Glove Factory is a specification developer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Latex Patient Examination Glove and 2 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | TRUE GLOVE FACTORY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009055041 |
| FEI number | 3009055041 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | NO.6-1 East XingAn Road, Linqu |
| Postal code | 262600 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Latex Patient Examination Glove | Class 1 | 2023 | 12 | |
| Medical Glove, Specialty | Class 1 | 2023 | 48 | |
| Polymer Patient Examination Glove | Class 1 | 2021 | 83 | |
| Vinyl Patient Examination Glove | Class 1 | Multiple | 2011 | 72 |
Clearances
2 clearances name True Glove Factory as applicant. 4 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 |
|---|---|---|---|---|
| K111012 | 2011-07-06 | LYZ | Traditional | This company |
| K110314 | 2011-05-10 | LYZ | Traditional | This company |
| K233182 | 2023-12-15 | LZA | Traditional | Zibo Kaiyue Mould Technology Co., Ltd. |
| K222074 | 2022-10-17 | LZA | Traditional | Zibo Langu New Material Technology Co., Ltd. |
| K182554 | 2019-03-22 | LZA | Traditional | HE Chuang Plastic & Rubber 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.