Heyuan Hongli Industries, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Heyuan Hongli Industries, Inc.” (first 2001, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 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 Heyuan Hongli Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030997 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | 2003-05-02 | 35 |
| K022305 | MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | LYZ | 2002-08-08 | 23 |
| K011414 | POWDERED VINAL EXAM GLOVES | LYZ | 2001-06-05 | 28 |
| K011413 | POWDER-FREE VINYL EXAM GLOVE, YELLOW | LYZ | 2001-06-05 | 28 |
| K011412 | POWDER-FREE VINYL EXAM GLOVES | LYZ | 2001-05-31 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Heyuan Hongli Industries, Inc..
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 Heyuan Hongli Industries, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Heyuan Hongli Industries, Inc.” (first 2001, latest 2003), 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 Heyuan Hongli Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heyuan Hongli Industries, Inc. is 28 days.
Which FDA product codes appear under Heyuan Hongli Industries, Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 5).
Next steps
- See all 5 Heyuan Hongli Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Heyuan Hongli Industries, Inc.'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.