Cleared Abbreviated

K252521 - LifeStyles® HydraFeel Natural Rubber Latex Condom (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K252521 · Suretex Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
99d
Days
Class 2
Risk

K252521 is an FDA 510(k) clearance for the LifeStyles® HydraFeel Natural Rubber Latex Condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suretex Limited (Suratthani, TH). The FDA issued a Cleared decision on November 18, 2025 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Suretex Limited devices

Submission Details

510(k) Number K252521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2025
Decision Date November 18, 2025
Days to Decision 99 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 160d · This submission: 99d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Digangi Consulting, LLC
DiGangi Donna

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 399
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K252521.
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K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
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K243640 · Church & Dwight Co., Inc. · Feb 2025
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LifeStyles NRL Textured Condom
K232279 · Suretex Limited · Oct 2023
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K230049 · Ttk Healthcare Limited · Sep 2023