Cleared Traditional

K150857 - Banana Gold

K150857 is an FDA 510(k) clearance for Banana Gold, manufactured by Hankook Latex Gongup Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K150857 · Hankook Latex Gongup Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
136d
Days
Class 2
Risk

K150857 is an FDA 510(k) clearance for the Banana Gold. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Hankook Latex Gongup Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on August 14, 2015 after a review of 136 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 Hankook Latex Gongup Co., Ltd. devices

FDA 510(k) Submission Details - K150857

510(k) Number K150857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2015
Decision Date August 14, 2015
Days to Decision 136 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 160d · This submission: 136d
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 Peers - HIS Condom

All 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K150857.
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
K161195 · M3 Global Enterprises, LLC · Aug 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · Lelo, Inc. · Jun 2016
O-RING Condom
K150828 · O-Ring Products, LLC · Dec 2015
TheyFit Male Condom
K150072 · Theyfit · Apr 2015
SKORE AND MULTIPLE BRANDS
K132490 · Ttk Protective Devices Limited (Formerly Ttk-Lig L · Oct 2014
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · Karex Industries Sdn. Bhd. · Aug 2014