Cleared Traditional

K262108 - FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin)

Also marketed or referenced as:
FAMA Male Latex Condoms – Aqueous Lubricant (Plain) FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed) FAMA Male Latex Condoms – Aqueous Lubricant (Dotted) FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped) MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin) MO Male Latex Condoms – Aqueous Lubricant (Plain) MO Male Latex Condoms – Aqueous Lubricant (Ribbed) MO Male Latex Condoms – Aqueous Lubricant (Dotted) MO

K262108 is an FDA 510(k) clearance for FAMA Male Latex Condoms – Aqueous Lubri..., manufactured by Shanghai Personage Hygiene Products Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K262108 · Shanghai Personage Hygiene Products Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
90d
Days
Class 2
Risk

K262108 is an FDA 510(k) clearance for the FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Shanghai Personage Hygiene Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 21, 2026 after a review of 90 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Personage Hygiene Products Co., Ltd. devices

FDA 510(k) Submission Details - K262108

510(k) Number K262108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2026
Decision Date September 21, 2026
Days to Decision 90 days
Submission Type Traditional
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
71d faster than avg
Panel avg: 161d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

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

Medwheat, Inc.
Vincent Zhou

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 240
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K262108.
Male Latex Condom HA
K252622 · Okamoto USA, Inc. · May 2026
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K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · Lelo, Inc. · Mar 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
K243640 · Church & Dwight Co., Inc. · Feb 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · Okamoto USA, Inc. · Feb 2025