Cleared Abbreviated

K081265 - THAI NIPPON MALE LATEX CONDOM (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081265 · Thai Nippon Rubber Industry Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
529d
Days
Class 2
Risk

K081265 is an FDA 510(k) clearance for the THAI NIPPON MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Co., Ltd. (Durham, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 529 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Thai Nippon Rubber Industry Co., Ltd. devices

Submission Details

510(k) Number K081265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date October 16, 2009
Days to Decision 529 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 160d · This submission: 529d
Pathway characteristics
Standards-based clearance path.

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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