Shanxi Hongjin Plastic Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shanxi Hongjin Plastic Technology Co., Ltd.” (first 2018, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 80 days, against 109 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 2 | 200 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 155 |
| 2022 | 1 | 58 |
| 2023 | 3 | 58 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shanxi Hongjin Plastic Technology Co., Ltd. took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 5 | 5 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (7)
Most recent Shanxi Hongjin Plastic Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | LZA | 2023-10-20 | 58 |
| K232353 | Powder Free Nitrile Examination Gloves (Black) | LZA | 2023-08-31 | 24 |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2023-06-09 | 80 |
| K220229 | Powder Free Nitrile Examination Gloves, Orange | LZA | 2022-03-26 | 58 |
| K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | LZA | 2021-10-27 | 155 |
| K180381 | Powder Free Vinyl Patient Examination Gloves | LYZ | 2018-11-07 | 268 |
| K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | LYZ | 2018-06-12 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Shanxi Hongjin Plastic 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.
- Shanxi Nacosa Medical Technology Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanxi Hongjin Plastic Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Shanxi Hongjin Plastic Technology Co., Ltd.” (first 2018, latest 2023), across 2 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 Shanxi Hongjin Plastic Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanxi Hongjin Plastic Technology Co., Ltd. is 80 days. Since 2017: 80 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanxi Hongjin Plastic Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 5); LYZ (Vinyl Patient Examination Glove, 2).
Next steps
- See all 7 Shanxi Hongjin Plastic Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Shanxi Hongjin Plastic 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.