Ansell, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Ansell, Inc.” (first 1980, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| HIS | Condom | 12 | 12 |
| LYY | Latex Patient Examination Glove | 12 | 12 |
| KGO | Surgeon'S Gloves | 4 | 4 |
| FMC | Patient Examination Glove | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
Most recent Ansell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984392 | ANSELL CONDOMS | HIS | 1999-07-21 | 225 |
| K983518 | LIFESTYLES XTRA PLEASURE | HIS | 1999-07-06 | 272 |
| K940047 | SPERMICIDALLY LUBRICATED CONDOM | HIS | 1995-12-19 | 713 |
| K953379 | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE | LYY | 1995-09-27 | 70 |
| K945766 | HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES | LYY | 1995-08-07 | 259 |
| K945767 | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES | LYY | 1995-03-02 | 101 |
| K940046 | NON-LUBRICATED CONDOM | HIS | 1995-01-30 | 390 |
| K940045 | CONDOM | HIS | 1995-01-30 | 390 |
| K913766 | ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES | LYY | 1993-03-11 | 567 |
| K914760 | LATEX EXAMINATION GLOVES | LYY | 1992-01-17 | 87 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ansell, 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.
- Ansell Healthcare Products, LLC (36 510(k)s)
- Ansell Perry (22 510(k)s)
- Ansell Intl. (4 510(k)s)
- Ansell Healthcare, Inc. (3 510(k)s)
- Ansell Edmont Industrial, Inc. (2 510(k)s)
- Ansell Pacific, Inc. (2 510(k)s)
- Ansell Heathcare Products, LLC (1 510(k)s)
- Ansell Malaysia Sdn Bhd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ansell, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Ansell, Inc.” (first 1980, latest 1999), across 5 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 Ansell, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ansell, Inc. is 74 days.
Which FDA product codes appear under Ansell, Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 12); LYY (Latex Patient Examination Glove, 12); KGO (Surgeon'S Gloves, 4).
Next steps
- See all 30 Ansell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Ansell, 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.