Kenwell International , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kenwell International , Ltd.” (first 1990, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 Kenwell International , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980412 | COLOURED POWDWR-FREE SURGICAL GLOVES | KGO | 1998-04-08 | 64 |
| K980803 | STERILE POWDER-FREE LATEX EXAMINATION GLOVES | LYY | 1998-04-03 | 32 |
| K963020 | GLOVEL GX | KGO | 1996-11-27 | 114 |
| K911134 | SURGICAL GLOVES | KGO | 1991-07-12 | 120 |
| K900811 | LATEX PATIENT EXAMINATION GLOVES | LYY | 1990-03-09 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Kenwell International , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kenwell International , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Kenwell International , Ltd.” (first 1990, latest 1998), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kenwell International , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kenwell International , Ltd. is 64 days.
Which FDA product codes appear under Kenwell International , Ltd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 5 Kenwell International , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Kenwell International , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.