Suretex Limited FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
LifeStyles® HydraFeel Natural Rubber Latex Condom510(k)Nov 18, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Abbreviated)	Nov 18, 2025
Polyisoprene Extra Large Condom510(k)May 9, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Abbreviated)	May 9, 2024
45 Micron Polyisoprene Condom510(k)Oct 27, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2023
LifeStyles NRL Textured Condom510(k)Oct 5, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Abbreviated)	Oct 5, 2023
OFNat Lubricant (L15)510(k)Sep 30, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2022
Microthin Natural Rubber Latex Condom510(k)Apr 28, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Abbreviated)	Apr 28, 2022