London International Group, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “London International Group, Inc.” (first 1997, latest 2000), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 155 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 | 2 | 2 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (5)
Most recent London International Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991677 | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) | LYY | 2000-04-12 | 331 |
| K984249 | SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE | LZA | 1999-05-04 | 155 |
| K980942 | REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE | KGO | 1998-05-11 | 60 |
| K980516 | REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE | KGO | 1998-04-23 | 72 |
| K971514 | REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE | LYY | 1997-10-29 | 187 |
Recalls
openFDA lists no recalls under a recalling firm named London International Group, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- London Diagnostics, Inc. (12 510(k)s)
- London Intl., LLC (6 510(k)s)
- London International U.S. Holdings, Inc. (2 510(k)s)
- London Rubber Co. (India) , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under London International Group, Inc.?
FDA lists 5 510(k) clearances under the applicant name “London International Group, Inc.” (first 1997, latest 2000), across 3 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 London International Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name London International Group, Inc. is 155 days.
Which FDA product codes appear under London International Group, Inc.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 2); LYY (Latex Patient Examination Glove, 2); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 5 London International Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, London International Group, Inc.'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.