Cleared Abbreviated

LifeStyles NRL Textured Condom

K232279 · Suretex Limited · Obstetrics & Gynecology
Oct 2023
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K232279 is an FDA 510(k) clearance for the LifeStyles NRL Textured Condom, a Condom (Class II — Special Controls, product code HIS), submitted by Suretex Limited (Tambon Khao Kwai, Amphur Phunphin, TH). The FDA issued a Cleared decision on October 5, 2023, 66 days after receiving the submission on July 31, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K232279 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2023
Decision Date October 05, 2023
Days to Decision 66 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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