Data / Medical devices / China / Inmed Gloves Factory
Inmed Gloves Factory: FDA-registered device maker in WEIFANG Shandong, China, 4 510(k) clearances
Inmed Gloves Factory is registered with the FDA (registration 3009211686) in WEIFANG Shandong, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009211686
- Address
- 10-2 Xingan Rd. East, Linqu, WEIFANG Shandong, China, 262600
- Owner or operator
- INMED GLOVES FACTORY (10038404)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 11, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 12, 2019 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | Substantially Equivalent | Shandong Hengya Packaging Printing 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 |
| September 21, 2011 | K111857 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Inmed Gloves Factory | accessdata.fda.gov |
| August 24, 2011 | K110621 | SHENGKUN CHEMICAL | LYZ | Substantially Equivalent | Zibo Shengkun Chemical Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 12, 2019. 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.