Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tangshan Hongyun Plastic Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
290 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211516 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Plastic Products Co., Ltd. | 2021-08-24 | 99 | 0 |
| K141878 | HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES | Tangshan Hongyun Plastic Products Co., Ltd. | 2014-12-24 | 166 | 0 |
| K142343 | Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( | Tangshan Hongyun Plastic Products Co., Ltd. | 2014-12-10 | 111 | 0 |
| K071999 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORE | Tangshan Hongyun Plastic Products Co., Ltd. | 2008-05-08 | 290 | 0 |
| K072001 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COL | Tangshan Hongyun Plastic Products Co., Ltd. | 2007-08-15 | 23 | 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