Data / Medical devices / China / Shandong Jieshi Intelligent Technology Co., Ltd.
Shandong Jieshi Intelligent Technology Co., Ltd.: FDA-registered device maker in Heze City Shandong, China, 2 510(k) clearances
Shandong Jieshi Intelligent Technology Co., Ltd. is registered with the FDA (registration 3015875006) in Heze City Shandong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015875006
- Address
- N. of Rd., 200M. from the cross of Hanjiang Rd. and Qinghe Mid-Rd., Qinghe St., Caoxian, Heze City Shandong, China, 274400
- Owner or operator
- Shandong Jieshi Intelligent Technology Co., Ltd. (10081946)
- Roles
- Manufacturer
- First device listed
- May 28, 2021
- Registered through
- 2026
- Brand names listed
- Powder Free Nitrile Patient Examination Glove, Blue Color, SHANDONG JIESHI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 2, 2021 | K210777 | Powder Free Nitrile Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Shandong Jieshi Medical Products Co., Ltd. | accessdata.fda.gov |
| May 14, 2021 | K210774 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | LYZ | Substantially Equivalent | Shandong Jieshi Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 2, 2021. 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.