Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transcorp · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
356 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922439 | LATEX EXAMINATION GLOVES | Transcorp | 1993-05-13 | 356 | 0 |
| K915189 | STERILETX POWDER FREE LATEX EXAMINATION GLOVES | Transcorp | 1992-02-27 | 101 | 0 |
| K904662 | SRI JOHANI LATEX SURGEONS GLOVES | Transcorp | 1991-01-11 | 88 | 0 |
| K903069 | KLEARTEX LATEX SURGICAL GLOVES | Transcorp | 1990-08-07 | 26 | 0 |
| K894569 | MEDPRIDE LATEX EXAMINATION GLOVES | Transcorp | 1989-08-24 | 34 | 0 |
| K891120 | TEXMED LATEX EXAMINATION GLOVE | Transcorp | 1989-03-24 | 22 | 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