Medigloves , Ltd.: FDA clearances and approvals
Medigloves , Ltd. has 6 FDA 510(k) clearances (first 1989, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time: 148 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 | 3 | 3 |
Review panels
- General Hospital (6)
Most recent Medigloves , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050181 | MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | 2005-04-13 | 76 |
| K930795 | MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES | LYY | 1994-02-03 | 352 |
| K930794 | MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES | KGO | 1994-02-03 | 352 |
| K912503 | HYPOALLERGENIC EXAMINATION LATEX GLOVES | LYY | 1991-09-06 | 113 |
| K912157 | HYPOALLERGENIC SURGICAL LATEX GLOVES | KGO | 1991-09-06 | 113 |
| K891326 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-09-13 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Medigloves , Ltd..
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 Medigloves , Ltd. have?
Medigloves , Ltd. has 6 FDA 510(k) clearances (first 1989, latest 2005), across 2 product codes in 1 review panel.
How long does FDA take to clear Medigloves , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Medigloves , Ltd.'s cleared 510(k)s is 148 days.
What devices does Medigloves , Ltd. make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 3); LYY (Latex Patient Examination Glove, 3).
Has Medigloves , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medigloves , Ltd. Related entities may recall under other names.
Next steps
- See all 6 Medigloves , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Medigloves , Ltd.'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.