Cleared Abbreviated

K070511 - RICHTER MALE LATEX CONDOM

K070511 is an FDA 510(k) clearance for RICHTER MALE LATEX CONDOM, manufactured by Richter Rubber Technology Sbn Bhd. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 326-day FDA review.

K070511 · Richter Rubber Technology Sbn Bhd · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
326d
Days
Class 2
Risk

K070511 is an FDA 510(k) clearance for the RICHTER MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Richter Rubber Technology Sbn Bhd (Durham, US). The FDA issued a Cleared decision on January 14, 2008 after a review of 326 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: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K070511

510(k) Number K070511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2007
Decision Date January 14, 2008
Days to Decision 326 days
Submission Type Abbreviated
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
165d slower than avg
Panel avg: 161d · This submission: 326d
Pathway characteristics
Standards-based clearance path.

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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K070511.
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
K081886 · Karex Industries Sdn. Bhd. · Feb 2009
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · Dailian Latex Company, Ltd. · Oct 2008
LOVE GUARD MALE LATEX CONDOM
K080833 · Tianjin Human-Care Latex Corporation · Aug 2008
UNIDUS MAGNUM MALE LATEX CONDOM
K072747 · Unidus Corp. · Nov 2007
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
K070511 · RICHTER MALE LATEX CONDOM
Download PDF FDA Summary Richter Rubber Techno…