Data / Medical devices / China / True Glove Factory
True Glove Factory: FDA-registered device maker in Weifang Shandong, China, 6 510(k) clearances
True Glove Factory is registered with the FDA (registration 3009055041) in Weifang Shandong, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009055041
- Address
- NO.6-1 East XingAn Road, Linqu, Weifang Shandong, China, 262600
- Owner or operator
- TRUE GLOVE FACTORY (10036844)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 31, 2011
- Registered through
- 2026
- Brand names listed
- Multiple
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2023 | K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | LZA | Substantially Equivalent | Zibo Kaiyue Mould Technology Co., Ltd. | accessdata.fda.gov |
| October 17, 2022 | K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | LZA | Substantially Equivalent | Zibo Langu New Material Technology Co., Ltd. | accessdata.fda.gov |
| March 22, 2019 | K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd. | accessdata.fda.gov |
| May 9, 2017 | K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd. | accessdata.fda.gov |
| July 6, 2011 | K111012 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) | LYZ | Substantially Equivalent | True Glove Factory | accessdata.fda.gov |
| May 10, 2011 | K110314 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) | LYZ | Substantially Equivalent | True Glove Factory | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Vinyl Patient Examination Glove
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.