Cleared Traditional

K150857 - Banana Gold

K150857 is the FDA 510(k) clearance for Banana Gold by Hankook Latex Gongup Co., Ltd.. It is a Class 2 Obstetrics & Gynecology device (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
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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

Submission Details

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.

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 Peers - HIS Condom

All 37
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K150857.
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
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000