Medical Device Manufacturer · TH , Tambon Khao Kwai, Amphur Phunphin

Suretex Limited - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2022

Recent clearances: LifeStyles® HydraFeel Natural Rubber Latex Condom, Polyisoprene Extra Large Condom, 45 Micron Polyisoprene Condom

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Suretex Limited Obstetrics & Gynecology ✕

6 devices
1-6 of 6
Cleared Nov 18, 2025
LifeStyles® HydraFeel Natural Rubber Latex Condom
K252521 · HIS
Obstetrics & Gynecology · 99d
Cleared May 09, 2024
Polyisoprene Extra Large Condom
K232470 · MOL
Obstetrics & Gynecology · 267d
Cleared Oct 27, 2023
45 Micron Polyisoprene Condom
K231908 · MOL
Obstetrics & Gynecology · 120d
Cleared Oct 05, 2023
LifeStyles NRL Textured Condom
K232279 · HIS
Obstetrics & Gynecology · 66d
Cleared Sep 30, 2022
OFNat Lubricant (L15)
K221243 · NUC
Obstetrics & Gynecology · 151d
Cleared Apr 28, 2022
Microthin Natural Rubber Latex Condom
K213921 · HIS
Obstetrics & Gynecology · 134d
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