510(k) K160399 ยท MOL Condom, Synthetic
Skyn Original Polyisoprene Lubricated Male Condom
| Applicant | Ansell Healthcare Products, LLC, Iselin NJ, US |
| Decision | Substantially Equivalent, Jul 25, 2016 |
| Received | Feb 12, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2022 | Family Dollar Stores, Llc. SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409
LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794
SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415 Open, Classified |
MOL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.