Shijiazhuang Hongray Plastic Products Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shijiazhuang Hongray Plastic Products Co., Ltd.” (first 1997, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 54 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Shijiazhuang Hongray Plastic Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994222 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR | LYZ | 2000-02-07 | 54 |
| K994206 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR | LYZ | 2000-02-07 | 55 |
| K992922 | SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR | LYZ | 1999-10-06 | 37 |
| K992860 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR | LYZ | 1999-09-24 | 30 |
| K982720 | H-RAY | LYZ | 1998-11-05 | 93 |
| K964321 | GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) | LYZ | 1997-01-09 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Shijiazhuang Hongray 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.
- Shijiazhuang Great Vision Plastic Products Co., LT (10 510(k)s)
- Shijiazhuang Junfei Plastic Products Co., Ltd. (6 510(k)s)
- Shijiazhuang Lianhe Shunda Plastic Products Co., L (6 510(k)s)
- Shijiazhuang Eversharp Plastic Products Co., Ltd. (5 510(k)s)
- Shijiazhuang Great Eagle Plastic Products Co., Ltd. (5 510(k)s)
- Shijiazhuang Hongxiang Plastics Products Co., Ltd. (5 510(k)s)
- Shijiazhuang Hongxiang Plastics Products Co; , Ltd. (4 510(k)s)
- Shijiazhuang Manful Light Industrial Products Co., (4 510(k)s)
- Shijiazhuang Wally Plastics Co., Ltd. (3 510(k)s)
- Shijiazhuang Winful Plastic Co., Ltd. (3 510(k)s)
- Shijiazhuang Brethern Plastic Co., Ltd. (2 510(k)s)
- Shijiazhuang Brilliance Plastic Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shijiazhuang Hongray Plastic Products Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shijiazhuang Hongray Plastic Products Co., Ltd.” (first 1997, latest 2000), 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 Shijiazhuang Hongray Plastic Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shijiazhuang Hongray Plastic Products Co., Ltd. is 54 days.
Which FDA product codes appear under Shijiazhuang Hongray Plastic Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6).
Next steps
- See all 6 Shijiazhuang Hongray Plastic Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Shijiazhuang Hongray 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.