Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi Tex, Inc. — 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) |
|---|---|---|---|---|---|
| K923901 | LATEX EXAMINATION GLOVES | Medi Tex, Inc. | 1992-12-04 | 122 | 0 |
| K901116 | STERILE LATEX PATIENT EXAMINATION GLOVES | Medi Tex, Inc. | 1990-04-25 | 47 | 0 |
| K891298 | AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) | Medi Tex, Inc. | 1989-03-29 | 16 | 0 |
| K840944 | INFUSION NEEDLE IIPN | Medi Tex, Inc. | 1984-04-13 | 39 | 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