Data / Medical devices / China / Pinnacle Co., Ltd
Pinnacle Co., Ltd: FDA-registered device maker in Linzi, Zibo Shandong, China, 3 510(k) clearances
Pinnacle Co., Ltd is registered with the FDA (registration 3006946173) in Linzi, Zibo Shandong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006946173
- Address
- Lot 2, No. 21 Qingtian Road Qilu Chemical Industrial Park, Linzi, Zibo Shandong, China, 255414
- Owner or operator
- Pinnacle Co., Ltd (10024624)
- Roles
- Manufacturer
- First device listed
- February 15, 2008
- Registered through
- 2026
- Brand names listed
- Omnishied, omnishield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| February 21, 2008 | K072223 | VINYL EXAMINATION GLOVE, POWDERED | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
| February 15, 2008 | K072227 | VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
| February 8, 2008 | K072228 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2008. 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.