Cleared Traditional

K171213 - One Touch Condom with Benzocaine

K171213 is an FDA 510(k) clearance for One Touch Condom with Benzocaine, manufactured by Thai Nippon Rubber Industry Public Company Limited.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K171213 · Thai Nippon Rubber Industry Public Company Limited. · Obstetrics & Gynecology device
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Jan 2018
Decision
262d
Days
Class 2
Risk

K171213 is an FDA 510(k) clearance for the One Touch Condom with Benzocaine. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Public Company Limited. (Bangkok, TH). The FDA issued a Cleared decision on January 12, 2018 after a review of 262 days - an extended review 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 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 Thai Nippon Rubber Industry Public Company Limited. devices

FDA 510(k) Submission Details - K171213

510(k) Number K171213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date January 12, 2018
Days to Decision 262 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 160d · This submission: 262d
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 59
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K171213.
Extremely Thin 003, ZERO ZERO THREE
K192669 · Okamoto USA, Inc. · Jul 2020
One Touch
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Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
K180104 · Church & Dwight Co., Inc. · Mar 2018
Lifestyles Zero Lubricated Latex Male Condom
K163107 · Ansell Healthcare Products, LLC · Jan 2017
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