Cleared Traditional

K895640 - MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

K895640 is an FDA 510(k) clearance for MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL ..., manufactured by Armkel, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K895640 · Armkel, LLC · Obstetrics & Gynecology device
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Jan 1990
Decision
126d
Days
Class 2
Risk

K895640 is an FDA 510(k) clearance for the MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on January 23, 1990 after a review of 126 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.

FDA 510(k) Submission Details - K895640

510(k) Number K895640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date January 23, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 161d · This submission: 126d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K895640.
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · Ansell, Inc. · Mar 1990
G.S.A. COLORED CONDOMS
K901112 · Ansell, Inc. · Mar 1990
SAFECON CONDOMS - PINK COLOR
K896623 · Quality Synthetics Intl, Inc. · Feb 1990
RIA (CONDOM)
K895091 · La Technology Sdn. Bhd. · Jan 1990
LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
K893217 · Shinhen Corp. · Jan 1990
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K896339 · Okamoto USA, Inc. · Jan 1990
K895640 · MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
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