TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379)
Description
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant by Church & Dwight Co., Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240379
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017 |
Trace the full predicate network for K240379
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.