Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hebei Titans Hongsen Medical Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
167 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2024-04-04 | 58 | 0 |
| K223895 | Disposable Medical Nitrile Examination Gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2023-03-23 | 85 | 0 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 | 167 | 0 |
| K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-08-18 | 43 | 0 |
| K211229 | Vinyl compound examination gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-07-29 | 97 | 0 |
| K182043 | Single-use medical poly (vinyl chloride) examination glove ( | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-09-21 | 53 | 0 |
| K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-08-10 | 102 | 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