Cleared Abbreviated

K990925 - MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

K990925 is an FDA 510(k) clearance for MALE NATURAL RUBBER LATEX CONDOM (WITH ..., manufactured by Hardcover Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K990925 · Hardcover Products, Inc. · Obstetrics & Gynecology device
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Jun 1999
Decision
90d
Days
Class 2
Risk

K990925 is an FDA 510(k) clearance for the MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Hardcover Products, Inc. (Concord, Ontario, CA). The FDA issued a Cleared decision on June 17, 1999 after a review of 90 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 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.

View all Hardcover Products, Inc. devices

FDA 510(k) Submission Details - K990925

510(k) Number K990925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date June 17, 1999
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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 134
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K990925.
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
SUMMER'S EVE LUBRICATING JELLY
K990597 · C.B. Fleet Co., Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
CLIMAX
K991049 · Medilatex Sdn. Bhd. · Jun 1999
INVIGRA
K991374 · Indus Medicare , Ltd. · Jun 1999
CVS PERSONAL LUBRICANT
K983216 · San-Mar Laboratories, Inc. · May 1999