Cleared Traditional

45 Micron Polyisoprene Condom

K231908 · Suretex Limited · Obstetrics & Gynecology
Oct 2023
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K231908 is an FDA 510(k) clearance for the 45 Micron Polyisoprene Condom, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Suretex Limited (Tambon Khao Kwai, Amphur Phunphin, TH). The FDA issued a Cleared decision on October 27, 2023, 120 days after receiving the submission on June 29, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K231908 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2023
Decision Date October 27, 2023
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MOL — Condom, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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