Zhonghong Pulin Medical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zhonghong Pulin Medical Products Co., Ltd.” (first 2016, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 170 days. Since 2017 the median was 174 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 |
|---|---|---|
| 2016 | 1 | 170 |
| 2017 | 1 | 145 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 0 | — |
| 2023 | 2 | 216 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhonghong Pulin Medical Products Co., Ltd. took a median 174 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 | 4 | 4 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Zhonghong Pulin Medical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | LZA | 2023-10-30 | 202 |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | LZA | 2023-10-26 | 230 |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | LYZ | 2021-05-17 | 90 |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | 2017-11-15 | 145 |
| K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | 2016-03-09 | 170 |
Recalls
openFDA lists no recalls under a recalling firm named Zhonghong Pulin Medical Products 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhonghong Pulin Medical Products Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Zhonghong Pulin Medical Products Co., Ltd.” (first 2016, 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 Zhonghong Pulin Medical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhonghong Pulin Medical Products Co., Ltd. is 170 days. Since 2017: 174 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhonghong Pulin Medical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 4); LYZ (Vinyl Patient Examination Glove, 1).
Next steps
- See all 5 Zhonghong Pulin Medical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Zhonghong Pulin Medical Products 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.