Hebei Hongtai Plastic Products Co.,Ltd.
Xingtai Hebei, CN
HEBEI HONGTAI PLASTIC PRODUCTS CO.,LTD. appears in FDA device records in Xingtai Hebei, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Hebei Hongtai Plastic Products Co.,Ltd. between 2010 and 2017. The busiest year on record is 2010, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) | LYZ | Substantially Equivalent | |
| K102819 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | |
| K102817 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009099927 | 3009099927 | HEBEI HONGTAI PLASTIC PRODUCTS CO.,LTD. | No 15, Luban Road , Julu county, Xingtai Hebei 055250 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain