Cleared Traditional

K990597 - SUMMER'S EVE LUBRICATING JELLY

K990597 is an FDA 510(k) clearance for SUMMER'S EVE LUBRICATING JELLY, manufactured by C.B. Fleet Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K990597 · C.B. Fleet Co., Inc. · Obstetrics & Gynecology device
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Jul 1999
Decision
145d
Days
Class 2
Risk

K990597 is an FDA 510(k) clearance for the SUMMER'S EVE LUBRICATING JELLY. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by C.B. Fleet Co., Inc. (Washington, US). The FDA issued a Cleared decision on July 19, 1999 after a review of 145 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.B. Fleet Co., Inc. devices

FDA 510(k) Submission Details - K990597

510(k) Number K990597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1999
Decision Date July 19, 1999
Days to Decision 145 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 160d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 204
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K990597.
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
K991892 · Line One Laboratories · Aug 1999
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
K992081 · Suretex Prophylactics (India) , Ltd. · Aug 1999
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
K990925 · Hardcover Products, Inc. · Jun 1999
CLIMAX
K991049 · Medilatex Sdn. Bhd. · Jun 1999