Hebei Hongsen Plastics Technology Co, Ltd.
Pennington, NJ, US
Hebei Hongsen Plastics Technology Co, Ltd. appears in FDA device records in Pennington, NJ. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Hebei Hongsen Plastics Technology Co, Ltd. between 2013 and 2017. The busiest year on record is 2014, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | LZA | Substantially Equivalent | |
| K140989 | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) | KGO | Substantially Equivalent | |
| K140988 | POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) | KGO | Substantially Equivalent | |
| K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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