Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ansell Healthcare Products, LLC · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
272 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherap | Ansell Healthcare Products, LLC | 2023-08-23 | 225 | 0 |
| K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with C | Ansell Healthcare Products, LLC | 2023-05-26 | 602 | 0 |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (B | Ansell Healthcare Products, LLC | 2022-03-10 | 244 | 0 |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Te | Ansell Healthcare Products, LLC | 2021-06-13 | 123 | 0 |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and C | Ansell Healthcare Products, LLC | 2020-06-19 | 98 | 0 |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Teste | Ansell Healthcare Products, LLC | 2019-05-23 | 139 | 0 |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemoth | Ansell Healthcare Products, LLC | 2019-03-22 | 150 | 0 |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | Ansell Healthcare Products, LLC | 2018-02-06 | 272 | 0 |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examinatio | Ansell Healthcare Products, LLC | 2017-12-29 | 200 | 0 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017-08-02 | 103 | 0 |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017-01-23 | 77 | 0 |
| K160974 | Gammex Cut-Resistant Glove Liner | Ansell Healthcare Products, LLC | 2016-10-28 | 204 | 0 |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016-07-25 | 164 | 1 |
| K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | 2016-03-09 | 260 | 0 |
| K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT | Ansell Healthcare Products, LLC | 2013-03-07 | 205 | 0 |
| K122720 | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT | Ansell Healthcare Products, LLC | 2013-02-22 | 170 | 0 |
| K122477 | LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT | Ansell Healthcare Products, LLC | 2013-02-19 | 189 | 0 |
| K122054 | LIFESTYLES NATURAL PERSONAL LUBRICANT | Ansell Healthcare Products, LLC | 2013-02-14 | 216 | 0 |
| K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TE | Ansell Healthcare Products, LLC | 2011-07-07 | 198 | 0 |
| K093523 | MICRO-TOUCH NITRILE | Ansell Healthcare Products, LLC | 2010-03-04 | 111 | 0 |
| K092327 | MICRO-TOUCH NITRA FREE | Ansell Healthcare Products, LLC | 2009-09-21 | 48 | 0 |
| K080536 | MICRO-TOUCH NITRAFREE | Ansell Healthcare Products, LLC | 2008-06-19 | 113 | 0 |
| K070800 | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM | Ansell Healthcare Products, LLC | 2008-03-06 | 349 | 0 |
| K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHET | Ansell Healthcare Products, LLC | 2007-12-13 | 169 | 0 |
| K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIE | Ansell Healthcare Products, LLC | 2005-08-17 | 47 | 8 |
| K043508 | DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURG | Ansell Healthcare Products, LLC | 2005-01-19 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda