Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Trade Management Co. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
81 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954462 | POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES | Intl. Trade Management Co. | 1995-10-13 | 18 | 0 |
| K953299 | POLYKOTE | Intl. Trade Management Co. | 1995-08-07 | 24 | 0 |
| K951513 | JAI | Intl. Trade Management Co. | 1995-05-25 | 52 | 0 |
| K950468 | POWDER FREE STERILE LATEX SURGEONS GLOVES | Intl. Trade Management Co. | 1995-04-25 | 81 | 0 |
| K950467 | POWDER FREE PATIENT EXAMINATION GLOVES | Intl. Trade Management Co. | 1995-04-25 | 81 | 0 |
| K946203 | JAI POWDERFREE LATEX EXAMINATION GLOVES | Intl. Trade Management Co. | 1995-02-27 | 68 | 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