Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hebei Hongsen Plastics Technology Co, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
249 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemoth | Hebei Hongsen Plastics Technology Co, Ltd. | 2017-02-13 | 96 | 0 |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOV | Hebei Hongsen Plastics Technology Co, Ltd. | 2015-06-18 | 127 | 0 |
| K140989 | POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME | Hebei Hongsen Plastics Technology Co, Ltd. | 2014-12-22 | 249 | 0 |
| K140988 | POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAN | Hebei Hongsen Plastics Technology Co, Ltd. | 2014-08-12 | 117 | 0 |
| K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | Hebei Hongsen Plastics Technology Co, Ltd. | 2013-09-25 | 128 | 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