Hong DI Plastic Products Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hong DI Plastic Products Co., Ltd.” (first 2007, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Hong DI Plastic Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102099 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 2010-10-06 | 71 |
| K102098 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 2010-09-27 | 62 |
| K101132 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) | LYZ | 2010-07-01 | 70 |
| K070188 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW | LYZ | 2007-03-19 | 56 |
| K070187 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE | LYZ | 2007-02-13 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Hong DI Plastic 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.
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.
- Hong Qiangxing (Shenzhen) Electronics Limited (9 510(k)s)
- Hong Seng Gloves Sdn Bhd (4 510(k)s)
- Hong Huang Tang Industrial Co., Ltd. (3 510(k)s)
- Hong YA Non-Woven Products Co., Ltd. (2 510(k)s)
- Hong Kong Etech Groups Limited (1 510(k)s)
- Hong Xin Rubber Products Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hong DI Plastic Products Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Hong DI Plastic Products Co., Ltd.” (first 2007, latest 2010), across 1 product code 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 Hong DI Plastic Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hong DI Plastic Products Co., Ltd. is 62 days.
Which FDA product codes appear under Hong DI Plastic Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 5).
Next steps
- See all 5 Hong DI Plastic Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Hong DI Plastic 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.