Data / Medical devices / China / Zibo Kaiyue Mould Technology Co., Ltd
Zibo Kaiyue Mould Technology Co., Ltd: FDA-registered device maker in Zibo Shandong, China, 3 510(k) clearances
Zibo Kaiyue Mould Technology Co., Ltd is registered with the FDA (registration 3030470903) in Zibo Shandong, China. It lists 3 device types. The FDA files 3 510(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
- 3030470903
- Address
- No. 268 Taishan Road, Guoli Town, Huantai County, Zibo Shandong, China, 256400
- Owner or operator
- Zibo Kaiyue Mould Technology Co., Ltd (10089458)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 9, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US | 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 |
| 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 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 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.