Cleared Abbreviated

K011253 - FLAVORED MALE LATEX CONDOM

K011253 is an FDA 510(k) clearance for FLAVORED MALE LATEX CONDOM, manufactured by Thai Nippon Rubber Industry Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

K011253 · Thai Nippon Rubber Industry Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
87d
Days
Class 2
Risk

K011253 is an FDA 510(k) clearance for the FLAVORED MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Co., Ltd. (Durham, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 87 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.

FDA 510(k) Submission Details - K011253

510(k) Number K011253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2001
Decision Date July 20, 2001
Days to Decision 87 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
74d faster than avg
Panel avg: 161d · This submission: 87d
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 Peers - HIS Condom

All 275
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K011253.
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K012962 · Innolatex Sdn. Bhd · Nov 2001
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
K012964 · Innolatex Sdn. Bhd · Nov 2001
MALE LATEX CONDOM
K012653 · Qingdao Shuang Die Latex Production Co.,Ltd · Sep 2001
MALE NATURAL RUBBER LATEX CONDOM
K010919 · Innolatex Sdn. Bhd · Jun 2001
VIVA
K011480 · Richter Rubber Technology Sdn. Bhd. · May 2001
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
K010371 · Suretex, Ltd. · Apr 2001