Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ergo Intl., Ent., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
100 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892166 | NON-STERILE PATIENT EXAM GLOVES (LATEX) | Ergo Intl., Ent., Inc. | 1989-07-14 | 100 | 0 |
| K892026 | PROLAX PATIENT EXAMINATION GLOVES (LATEX) | Ergo Intl., Ent., Inc. | 1989-05-25 | 56 | 0 |
| K892100 | PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.) | Ergo Intl., Ent., Inc. | 1989-05-08 | 35 | 0 |
| K892101 | PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES) | Ergo Intl., Ent., Inc. | 1989-05-08 | 35 | 0 |
| K884030 | ERGO II, SURGICAL LATEX GLOVES | Ergo Intl., Ent., Inc. | 1988-11-07 | 45 | 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