Cleared Traditional

K960710 - CONDOM

K960710 is an FDA 510(k) clearance for CONDOM, manufactured by Polar Latex , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K960710 · Polar Latex , Ltd. · Obstetrics & Gynecology device
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Oct 1996
Decision
232d
Days
Class 2
Risk

K960710 is an FDA 510(k) clearance for the CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Polar Latex , Ltd. (Julian, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 232 days - an extended review 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 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 Polar Latex , Ltd. devices

FDA 510(k) Submission Details - K960710

510(k) Number K960710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date October 10, 1996
Days to Decision 232 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
72d slower than avg
Panel avg: 160d · This submission: 232d
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 146
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K960710.
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
K964599 · Line One Laboratories · Feb 1997
TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
K964591 · Line One Laboratories · Feb 1997
SAFE KNIGHTS
K955183 · L & N Corp. · Feb 1997
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · Line One Laboratories & Trading Co. · Jul 1996
K-Y PERSONAL LUBRICANT
K955648 · Ortho Pharmaceutical Corp. · Jun 1996
RIA LATEX CONDOM, NONOXYNOL-9
K945145 · Mbf Personal Care Sdn. Bhd. · Feb 1996