Cleared Abbreviated

Polyisoprene Extra Large Condom

K232470 · Suretex Limited · Obstetrics & Gynecology
May 2024
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K232470 is an FDA 510(k) clearance for the Polyisoprene Extra Large Condom, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Suretex Limited (Suratthani, TH). The FDA issued a Cleared decision on May 9, 2024, 267 days after receiving the submission on August 16, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K232470 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2023
Decision Date May 09, 2024
Days to Decision 267 days
Submission Type Abbreviated
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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