Cleared Traditional

K983320 - ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS

K983320 is an FDA 510(k) clearance for ROYALE BRAND LATEX CONDOMS SILICONE LUB..., manufactured by Suretex Prophylactics (India) , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K983320 · Suretex Prophylactics (India) , Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
81d
Days
Class 2
Risk

K983320 is an FDA 510(k) clearance for the ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suretex Prophylactics (India) , Ltd. (Bangalore, Karnataka, IN). The FDA issued a Cleared decision on December 11, 1998 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Suretex Prophylactics (India) , Ltd. devices

FDA 510(k) Submission Details - K983320

510(k) Number K983320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date December 11, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 160d · This submission: 81d
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 109
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K983320.
SURE
K982380 · Pleasure Latex Products Sdn. Bhd. · Feb 1999
SHEER THIN
K984488 · Twe Companies, Inc. · Feb 1999
OASIS
K984218 · Glimex Corp. · Dec 1998
DUREX SENSIDOM LATEX CONDOM
K982924 · London Intl., LLC · Nov 1998
DUREX LUBRAGEL LATEX CONDOM
K983380 · London Intl., LLC · Nov 1998
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
K982673 · Key West Fragrance & Cosmetic · Oct 1998