Cleared Traditional

K981621 - ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

K981621 is an FDA 510(k) clearance for ROYALE OF LATEX CONDOMS - SPERMICIDAL L..., manufactured by Suretex Prophylactics (India) , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K981621 · Suretex Prophylactics (India) , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
44d
Days
Class 2
Risk

K981621 is an FDA 510(k) clearance for the ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Suretex Prophylactics (India) , Ltd. (Bangalore, Karnataka, IN). The FDA issued a Cleared decision on June 19, 1998 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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 - K981621

510(k) Number K981621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1998
Decision Date June 19, 1998
Days to Decision 44 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
116d faster than avg
Panel avg: 160d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTZ Device Classification - Class 2, Special Controls

Product Code LTZ Condom With Nonoxynol-9
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5310
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 - LTZ Condom With Nonoxynol-9

All 8
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K981621.
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · Ls Rubber Sdn Bhd · Mar 1999
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · Reddy Medtech Health Products , Ltd. · Feb 1998
LATEX CONDOMS (NATURAL COLOUR)
K974326 · Reddy Medtech Health Products , Ltd. · Feb 1998
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K972836 · G. Premjee (Usa), Inc. · Oct 1997
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972429 · Custom Services Intl., Inc. · Sep 1997
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972430 · Custom Services Intl., Inc. · Sep 1997