Cleared Abbreviated

K161195 - Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

K161195 is an FDA 510(k) clearance for Royal Condoms (Natural, manufactured by M3 Global Enterprises, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 120-day FDA review.

K161195 · M3 Global Enterprises, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
120d
Days
Class 2
Risk

K161195 is an FDA 510(k) clearance for the Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by M3 Global Enterprises, LLC (Beavercreek, US). The FDA issued a Cleared decision on August 25, 2016 after a review of 120 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.

FDA 510(k) Submission Details - K161195

510(k) Number K161195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date August 25, 2016
Days to Decision 120 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
41d faster than avg
Panel avg: 161d · This submission: 120d
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

Registrar Corp.
Lara Luzak

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 355
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K161195.
aoni Natural Rubber Latex Condom
K153016 · Guangzhou Daming United Rubber Products , Ltd. · Oct 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161915 · Church & Dwight Co., Inc. · Sep 2016
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161545 · Church & Dwight Co., Inc. · Aug 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · Lelo, Inc. · Jun 2016
O-RING Condom
K150828 · O-Ring Products, LLC · Dec 2015
Banana Gold
K150857 · Hankook Latex Gongup Co., Ltd. · Aug 2015
K161195 · Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
Download PDF FDA Summary M3 Global Enterprises…