Cleared Traditional

TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM (K081413) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081413 · Dailian Latex Company, Ltd. · Obstetrics & Gynecology device
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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

Submission Details

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.

Device Classification

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.

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