510(k) K120394 ยท HIS Condom
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
| Applicant | Ansell Heathcare Products, LLC, Dothan AL, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Feb 8, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K120394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Ansell Healthcare Products LLC LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303.
A sheath which completely covers the penis with a closely fitting membrane. The cond Terminated |
HIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.