Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ever Global (Vietnam) Enterprise Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
198 daysmedian FDA review time
216 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 | 34 | 0 |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color | Ever Global (Vietnam) Enterprise Corporation | 2025-02-06 | 38 | 0 |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | 2023-02-06 | 216 | 0 |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | 2022-10-19 | 198 | 0 |
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tes | Ever Global (Vietnam) Enterprise Corporation | 2019-09-06 | 199 | 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