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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 161d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K081413.
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · Alatech Healthcare, LLC · May 2009
OKAMOTO ULTRA THIN
K090259 · Okamoto USA, Inc. · Mar 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
K081886 · Karex Industries Sdn. Bhd. · Feb 2009
LOVE GUARD MALE LATEX CONDOM
K080833 · Tianjin Human-Care Latex Corporation · Aug 2008
RICHTER MALE LATEX CONDOM
K070511 · Richter Rubber Technology Sbn Bhd · Jan 2008
UNIDUS MAGNUM MALE LATEX CONDOM
K072747 · Unidus Corp. · Nov 2007

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K081413 · TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
Download PDF FDA Summary Dailian Latex Company…