Ansell Healthcare Products, LLC: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Ansell Healthcare Products, LLC” (first 2000, latest 2023), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 128 days. Since 2017 the median was 150 days, against 123 days for all cleared 510(k)s in the same product codes. 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 | 4 | 197 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 204 |
| 2017 | 3 | 103 |
| 2018 | 1 | 272 |
| 2019 | 2 | 144 |
| 2020 | 1 | 98 |
| 2021 | 1 | 123 |
| 2022 | 1 | 244 |
| 2023 | 2 | 414 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ansell Healthcare Products, LLC took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 16 | 16 |
| LZA | Polymer Patient Examination Glove | 10 | 10 |
| NUC | Lubricant, Personal | 4 | 4 |
| MOL | Condom, Synthetic | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| HIS | Condom | 1 | 1 |
Review panels
Most recent Ansell Healthcare Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | KGO | 2023-08-23 | 225 |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | KGO | 2023-05-26 | 602 |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | LZA | 2022-03-10 | 244 |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2021-06-13 | 123 |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | LZA | 2020-06-19 | 98 |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | 2019-05-23 | 139 |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | 2019-03-22 | 150 |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | KGO | 2018-02-06 | 272 |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | LZA | 2017-12-29 | 200 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | MOL | 2017-08-02 | 103 |
26 earlier clearances. See the full list in Caduvo.
Recalls
27 product recalls in 10 recall events; 3 initiated in the last five years. Most recent: 2023-08-03.
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, Inc. (30 510(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 Healthcare Products, LLC?
FDA lists 36 510(k) clearances under the applicant name “Ansell Healthcare Products, LLC” (first 2000, latest 2023), across 6 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 Healthcare Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ansell Healthcare Products, LLC is 128 days. Since 2017: 150 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ansell Healthcare Products, LLC?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 16); LZA (Polymer Patient Examination Glove, 10); NUC (Lubricant, Personal, 4).
Next steps
- See all 36 Ansell Healthcare Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code KGO, Ansell Healthcare Products, LLC'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.