Hebei Hongsen Plastics Technology Co, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hebei Hongsen Plastics Technology Co, Ltd.” (first 2013, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 127 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 128 |
| 2014 | 2 | 183 |
| 2015 | 1 | 127 |
| 2016 | 0 | — |
| 2017 | 1 | 96 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hebei Hongsen Plastics Technology Co, Ltd. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Hebei Hongsen Plastics Technology Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | LZC | 2017-02-13 | 96 |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | LZA | 2015-06-18 | 127 |
| K140989 | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) | KGO | 2014-12-22 | 249 |
| K140988 | POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) | KGO | 2014-08-12 | 117 |
| K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | 2013-09-25 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Hebei Hongsen Plastics Technology Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hebei Titans Hongsen Medical Technology Co., Ltd. (7 510(k)s)
- Hebei Handform Plastic Products Co., Ltd. (4 510(k)s)
- Hebei Hongtai Plastic Products Co., Ltd. (3 510(k)s)
- Hebei JT Medical Co., Ltd. (3 510(k)s)
- Hebei Keylaser Sci-Tech Co.,Ltd (3 510(k)s)
- Hebei Zhemai Technology Co., Ltd. (3 510(k)s)
- Hebei Astro Medical Supply Co., Ltd. (2 510(k)s)
- Hebei Excellent Plastic Co., Ltd. (2 510(k)s)
- Hebei Manful Import & Export Co., Ltd. (2 510(k)s)
- Hebei Newangie Technology Co., Ltd. (2 510(k)s)
- Hebei Shenzichen Plastic & Rubber Products Co., LT (2 510(k)s)
- Hebei Tengda Plastic Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hebei Hongsen Plastics Technology Co, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Hebei Hongsen Plastics Technology Co, Ltd.” (first 2013, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hebei Hongsen Plastics Technology Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hebei Hongsen Plastics Technology Co, Ltd. is 127 days.
Which FDA product codes appear under Hebei Hongsen Plastics Technology Co, Ltd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 2); LZA (Polymer Patient Examination Glove, 2); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 5 Hebei Hongsen Plastics Technology Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Hebei Hongsen Plastics Technology Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.