Cleared Abbreviated

K991047 - HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

K991047 is an FDA 510(k) clearance for HARDCOVER CONDOMS MALE LATEX CONDOMS, manufactured by Hardcover Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K991047 · Hardcover Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
80d
Days
Class 2
Risk

K991047 is an FDA 510(k) clearance for the HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE). Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Hardcover Products, Inc. (Concord, Ontario, CA). The FDA issued a Cleared decision on June 18, 1999 after a review of 80 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.

View all Hardcover Products, Inc. devices

FDA 510(k) Submission Details - K991047

510(k) Number K991047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date June 18, 1999
Days to Decision 80 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
80d faster than avg
Panel avg: 160d · This submission: 80d
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 11
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K991047.
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · Indus Medicare , Ltd. · Aug 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669 · Dongkuk Techco Rubber Industries Sdn. Bhd. · May 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · Ls Rubber Sdn Bhd · Mar 1999
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621 · Suretex Prophylactics (India) , Ltd. · Jun 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · Reddy Medtech Health Products , Ltd. · Feb 1998
LATEX CONDOMS (NATURAL COLOUR)
K974326 · Reddy Medtech Health Products , Ltd. · Feb 1998