Data / Medical devices / China / Novapro Co. Ltd.
Novapro Co. Ltd.: FDA-registered device maker in Zibo Shandong, China, 4 510(k) clearances
Novapro Co. Ltd. is registered with the FDA (registration 3007842555) 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 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
- 3007842555
- Address
- Lot4, No.21 Qingtian Road, Zibo Shandong, China, 255414
- Owner or operator
- NOVAPRO CO. LTD. (10030154)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 20, 2009
- Registered through
- 2026
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 | Exporter to the US, Manufacturer, Specification developer | 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 |
| August 24, 2011 | K110621 | SHENGKUN CHEMICAL | LYZ | Substantially Equivalent | Zibo Shengkun Chemical Industrial Co., Ltd. | accessdata.fda.gov |
| July 30, 2009 | K091422 | NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Novapro Co., Ltd. | accessdata.fda.gov |
| July 23, 2009 | K091421 | NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) | LYZ | Substantially Equivalent | Novapro 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.