Data / Medical devices / China / Shandong Huayue Glove Co., Ltd.
Shandong Huayue Glove Co., Ltd.: FDA-registered device maker in Zibo Shandong, China, 4 510(k) clearances
Shandong Huayue Glove Co., Ltd. is registered with the FDA (registration 3007707004) in Zibo Shandong, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 17, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007707004
- Address
- East of Yifan Rd. and North of Naqi Rd. Science and Technology Based Ind. Zone, Zibo Shandong, China, 255400
- Owner or operator
- Shandong Huayue Glove Co., Ltd. (10029444)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 14, 2009
- Registered through
- 2026
- Brand names listed
- Huayue
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| May 18, 2009 | K090520 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
| May 8, 2009 | K090513 | VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
Updated October 17, 2022. 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.