Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maytex Corp. · 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) |
|---|---|---|---|---|---|
| K935314 | MAYTEX LATEX EXAMINATION GLOVES, POWDERED | Maytex Corp. | 1994-08-01 | 272 | 0 |
| K935315 | MAYTEX POWDER-FREE LATEX EXAMINATION GLOVES | Maytex Corp. | 1994-08-01 | 272 | 0 |
| K892082 | MAYTEX NON-STERILE LATEX EXAM GLOVES | Maytex Corp. | 1989-05-31 | 58 | 0 |
| K892183 | MAYTEX LATEX EXAMINATION GLOVES | Maytex Corp. | 1989-05-31 | 56 | 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