Class Class II
0.04 ZERO ZERO FOUR Male Latex Condom (K243584)
Description
0.04 ZERO ZERO FOUR Male Latex Condom by Okamoto USA, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243584
Clearance Date2025-02-18
Clearance TypeAbbreviated
Product CodeHIS
Regulation Number884.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243584
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. 0.04 ZERO ZERO FOUR Male Latex Condom (K243584) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140379 | MEGA BIG BOY CONDOM | Okamoto USA, Inc. | 2014 |
Trace the full predicate network for K243584
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.