Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Regent Hospital Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951908 | REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE | Regent Hospital Products | 1995-09-01 | 130 | 0 |
| K910928 | RUBBER LATEX SURGEONS GLOVES | Regent Hospital Products | 1991-06-13 | 100 | 0 |
| K902601 | REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS | Regent Hospital Products | 1990-08-10 | 59 | 0 |
| K896432 | RUBBER LATEX SURGEON'S GLOVE | Regent Hospital Products | 1990-02-01 | 85 | 0 |
| K891658 | REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES | Regent Hospital Products | 1989-06-06 | 78 | 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