Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
London International Group, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
331 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991677 | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL D | London International Group, Inc. | 2000-04-12 | 331 | 0 |
| K984249 | SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION | London International Group, Inc. | 1999-05-04 | 155 | 0 |
| K980942 | REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE | London International Group, Inc. | 1998-05-11 | 60 | 0 |
| K980516 | REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE | London International Group, Inc. | 1998-04-23 | 72 | 0 |
| K971514 | REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE | London International Group, Inc. | 1997-10-29 | 187 | 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