Cleared Traditional

K081413 - TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM

K081413 is an FDA 510(k) clearance for TWINLOTUS AND SHIELDS NATURAL RUBBER LA..., manufactured by Dailian Latex Company, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K081413 · Dailian Latex Company, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
157d
Days
Class 2
Risk

K081413 is an FDA 510(k) clearance for the TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Dailian Latex Company, Ltd. (Dailian City, Liaoning, CN). The FDA issued a Cleared decision on October 24, 2008 after a review of 157 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 Dailian Latex Company, Ltd. devices

FDA 510(k) Submission Details - K081413

510(k) Number K081413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date October 24, 2008
Days to Decision 157 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 160d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 114
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K081413.
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
K131887 · Church & Dwight Co., Inc. · Oct 2013
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
K120286 · Church & Dwight Co., Inc. · Jun 2012
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
K120287 · Church & Dwight Co., Inc. · May 2012
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007