Cleared Traditional

K896098 - GUARDIAN & JANITEX CONDOM/PROPHYLACTIC

K896098 is an FDA 510(k) clearance for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC, manufactured by Allied Rubber Industries Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 425-day FDA review.

K896098 · Allied Rubber Industries Sdn. Bhd. · Obstetrics & Gynecology device
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Dec 1990
Decision
425d
Days
Class 2
Risk

K896098 is an FDA 510(k) clearance for the GUARDIAN & JANITEX CONDOM/PROPHYLACTIC. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Allied Rubber Industries Sdn. Bhd. (400000 Shah Alam.Malaysia, MY). The FDA issued a Cleared decision on December 19, 1990 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Allied Rubber Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K896098

510(k) Number K896098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1989
Decision Date December 19, 1990
Days to Decision 425 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 160d · This submission: 425d
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 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K896098.
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · Armkel, LLC · Feb 1991
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · Aladan Corp. · Feb 1991
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990