Company ยท US
Ansell Healthcare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2023. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2023 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hy Ansell Healthcare | KGO |
| Dec 19, 2003 | K033076 | LIFESTYLES LIQUID PERSONAL LUBRICANT Ansell Healthcare, Inc. | HIS |
| Jul 31, 2000 | K001883 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM Ansell Healthcare, Inc. | HIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2002 | Ansell Healthcare Inc LifeStyles Assorted Colors Condoms with Spermicide Terminated |
LTZ | K000408 K971132 +1 |
| Dec 31, 2002 | Ansell Healthcare Inc Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors Terminated |
HIS | None listed |