Regent Hospital Products: FDA clearances and approvals
Regent Hospital Products has 5 FDA 510(k) clearances (first 1989, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time: 85 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Regent Hospital Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951908 | REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE | KGO | 1995-09-01 | 130 |
| K910928 | RUBBER LATEX SURGEONS GLOVES | KGO | 1991-06-13 | 100 |
| K902601 | REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS | LYY | 1990-08-10 | 59 |
| K896432 | RUBBER LATEX SURGEON'S GLOVE | KGO | 1990-02-01 | 85 |
| K891658 | REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES | LYY | 1989-06-06 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Regent Hospital Products.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Regent Hospital Products have?
Regent Hospital Products has 5 FDA 510(k) clearances (first 1989, latest 1995), across 2 product codes in 1 review panel.
How long does FDA take to clear Regent Hospital Products's 510(k)s?
The median time from FDA receipt to decision across Regent Hospital Products's cleared 510(k)s is 85 days.
What devices does Regent Hospital Products make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 3); LYY (Latex Patient Examination Glove, 2).
Has Regent Hospital Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Regent Hospital Products. Related entities may recall under other names.
Next steps
- See all 5 Regent Hospital Products clearances with predicates and recalls
- Run predicate analysis for product code KGO, Regent Hospital Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.