Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Est International Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040108 | OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WI | Est International Corporation | 2004-08-17 | 210 | 0 |
| K041325 | DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE | Est International Corporation | 2004-07-02 | 45 | 0 |
| K032236 | DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Est International Corporation | 2003-08-26 | 36 | 0 |
| K032272 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COL | Est International Corporation | 2003-08-26 | 34 | 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