Cleared Abbreviated

K001978 - 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

K001978 is an FDA 510(k) clearance for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9, manufactured by Thai Nippon Rubber Industry Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Abbreviated 510(k) pathway after a 40-day FDA review.

K001978 · 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
Aug 2000
Decision
40d
Days
Class 2
Risk

K001978 is an FDA 510(k) clearance for the 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Co., Ltd. (Durham, US). The FDA issued a Cleared decision on August 8, 2000 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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 - K001978

510(k) Number K001978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2000
Decision Date August 08, 2000
Days to Decision 40 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
121d faster than avg
Panel avg: 161d · This submission: 40d
Pathway characteristics
Standards-based clearance path.

LTZ Device Classification - Class 2, Special Controls

Product Code LTZ Condom With Nonoxynol-9
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5310
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 - LTZ Condom With Nonoxynol-9

All 21
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K001978.
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
K012969 · Medtech Products , Ltd. · Jun 2002
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · Innolatex Sdn. Bhd · Apr 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
K003375 · Tecnilatex S.A. · Jan 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K001377 · Pleasure Latex Products Sdn. Bhd. · Jun 2000
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · Indus Medicare , Ltd. · Aug 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047 · Hardcover Products, Inc. · Jun 1999