Data / Medical devices / China / Zibo Intco Medical Products Company Limited
Zibo Intco Medical Products Company Limited: FDA-registered device maker in Zibo Shandong, China, 3 510(k) clearances
Zibo Intco Medical Products Company Limited is registered with the FDA (registration 3008191396) in Zibo Shandong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 1, 2014. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008191396
- Address
- 18 Qingtian Road, Qilu Chem. Ind. Park, Linzi, Zibo Shandong, China, 255414
- Owner or operator
- Zibo Intco Medical Products Company Limited (10031179)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 29, 2009
- Registered through
- 2026
- Brand names listed
- Face Shields, Isolation Gown, Powder-Free Vinyl Patient Examination Gloves, Yellow Color, Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue, Vinyl Examination Glove, Powder Free,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 1, 2014 | K132637 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR | LYZ | Substantially Equivalent | Zibo Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| November 27, 2013 | K132201 | SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR | LYZ | Substantially Equivalent | Zibo Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| September 21, 2009 | K091942 | POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Intco Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Non-Surgical Gown
- All makers of Gown, Examination
- All makers of Accessory, Surgical Apparel
Updated May 1, 2014. 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.