Aladan Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Aladan Corp.” (first 1989, latest 1996), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 14 | 14 |
| HIS | Condom | 4 | 4 |
Review panels
Most recent Aladan Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960590 | TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE | LYY | 1996-10-31 | 262 |
| K952404 | SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE | LYY | 1995-07-20 | 59 |
| K952556 | SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE | LYY | 1995-06-26 | 24 |
| K943933 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | HIS | 1995-06-22 | 314 |
| K951839 | ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES | LYY | 1995-06-15 | 56 |
| K943883 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | HIS | 1995-04-14 | 248 |
| K942758 | HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE | LYY | 1994-07-08 | 25 |
| K940873 | SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE | LYY | 1994-04-22 | 56 |
| K911774 | ALADAN LATEX MEDICAL GLOVE | LYY | 1991-05-03 | 14 |
| K911447 | LATEX EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | 1991-04-16 | 39 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aladan Corp..
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 Aladan Corp.?
FDA lists 18 510(k) clearances under the applicant name “Aladan Corp.” (first 1989, latest 1996), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aladan Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aladan Corp. is 41 days.
Which FDA product codes appear under Aladan Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 14); HIS (Condom, 4).
Next steps
- See all 18 Aladan Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Aladan Corp.'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.