Data / Medical devices / China / Hebei Hongtai Plastic Products Co.,ltd.
Hebei Hongtai Plastic Products Co.,ltd.: FDA-registered device maker in Xingtai Hebei, China, 3 510(k) clearances
Hebei Hongtai Plastic Products Co.,ltd. is registered with the FDA (registration 3009099927) in Xingtai Hebei, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2017. 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
- 3009099927
- Address
- No 15, Luban Road, Julu county, Xingtai Hebei, China, 055250
- Owner or operator
- Hebei Hongtai Plastic Products Co.,Ltd. (10036565)
- Roles
- Manufacturer
- First device listed
- May 16, 2011
- Registered through
- 2026
- Brand names listed
- Blue Vitrile Examination gloves Mediglove Brand, Nitrile Compound Vinyl Exam Gloves-S M L XL
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 23, 2017 | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) | LYZ | Substantially Equivalent | Hebei Hongtai Plastic Products Company Limited | accessdata.fda.gov |
| December 23, 2010 | K102819 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Hebei Hongtai Plastic Products Co., Ltd. | accessdata.fda.gov |
| December 23, 2010 | K102817 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Hebei Hongtai Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2017. 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.