Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanxi Hongjin Plastic Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
268 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-10-20 | 58 | 0 |
| K232353 | Powder Free Nitrile Examination Gloves (Black) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-08-31 | 24 | 0 |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for U | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-06-09 | 80 | 0 |
| K220229 | Powder Free Nitrile Examination Gloves, Orange | Shanxi Hongjin Plastic Technology Co., Ltd. | 2022-03-26 | 58 | 0 |
| K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Us | Shanxi Hongjin Plastic Technology Co., Ltd. | 2021-10-27 | 155 | 0 |
| K180381 | Powder Free Vinyl Patient Examination Gloves | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018-11-07 | 268 | 0 |
| K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018-06-12 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda