Tangshan Hongyun Plastic Products Co., Ltd.: FDA clearances and approvals
Tangshan Hongyun Plastic Products Co., Ltd. has 5 FDA 510(k) clearances (first 2007, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time: 111 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 138 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 99 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Tangshan Hongyun Plastic Products Co., Ltd.'s cleared 510(k)s took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Tangshan Hongyun Plastic Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211516 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | LYZ | 2021-08-24 | 99 |
| K141878 | HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES | LYZ | 2014-12-24 | 166 |
| K142343 | Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) | LYZ | 2014-12-10 | 111 |
| K071999 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | 2008-05-08 | 290 |
| K072001 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | 2007-08-15 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Tangshan Hongyun Plastic Products Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tangshan Hongyun Plastic Products Co., Ltd. have?
Tangshan Hongyun Plastic Products Co., Ltd. has 5 FDA 510(k) clearances (first 2007, latest 2021), across 1 product code in 1 review panel.
How long does FDA take to clear Tangshan Hongyun Plastic Products Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Tangshan Hongyun Plastic Products Co., Ltd.'s cleared 510(k)s is 111 days.
What devices does Tangshan Hongyun Plastic Products Co., Ltd. make?
Its most frequent FDA product codes are LYZ (Vinyl Patient Examination Glove, 5).
Has Tangshan Hongyun Plastic Products Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tangshan Hongyun Plastic Products Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Tangshan Hongyun Plastic Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Tangshan Hongyun Plastic Products Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.