Cleared Abbreviated

K172414 - JUD custom fit condom

K172414 is an FDA 510(k) clearance for JUD custom fit condom, manufactured by Global Mailer Partners, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K172414 · Global Mailer Partners, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
63d
Days
Class 2
Risk

K172414 is an FDA 510(k) clearance for the JUD custom fit condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Global Mailer Partners, LLC (Miami Beach, US). The FDA issued a Cleared decision on October 12, 2017 after a review of 63 days - a notably fast clearance cycle.

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 Global Mailer Partners, LLC devices

FDA 510(k) Submission Details - K172414

510(k) Number K172414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2017
Decision Date October 12, 2017
Days to Decision 63 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
97d faster than avg
Panel avg: 160d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

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

Target Health, Inc.
Adam Harris

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 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K172414.
One Touch
K181844 · Thai Nippon Rubber Industry Public Company, Ltd. · Apr 2019
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
K180104 · Church & Dwight Co., Inc. · Mar 2018
One Touch Condom with Benzocaine
K171213 · Thai Nippon Rubber Industry Public Company Limited. · Jan 2018
Male Latex Condoms
K162919 · Zhejiang Xiangban Latex Products Co., Ltd. · Mar 2017
Lifestyles Zero Lubricated Latex Male Condom
K163107 · Ansell Healthcare Products, LLC · Jan 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · Lelo, Inc. · Jan 2017