Cleared Abbreviated

K994095 - LATEX CONDOM

K994095 is an FDA 510(k) clearance for 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 46-day FDA review.

K994095 · 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
Jan 2000
Decision
46d
Days
Class 2
Risk

K994095 is an FDA 510(k) clearance for the 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 January 18, 2000 after a review of 46 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 - K994095

510(k) Number K994095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date January 18, 2000
Days to Decision 46 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
115d faster than avg
Panel avg: 161d · This submission: 46d
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 K994095.
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
K993779 · P.T. Vonix Latexindo Condom (Rubber) Mfg. · Feb 2000
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
K993781 · P.T. Vonix Latexindo Condom (Rubber) Mfg. · Feb 2000
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K993782 · P.T. Vonix Latexindo Condom (Rubber) Mfg. · Feb 2000
INVIGRA
K993693 · Indus Medicare , Ltd. · Dec 1999
ALATECH LATEX CONDOM
K993887 · Alatech Healthcare, LLC · Dec 1999
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
K991892 · Line One Laboratories · Aug 1999