Cleared Traditional

K041432 - ASTROGLIDE BRAND WARMING LIQUID PERSONA...

K041432 is an FDA 510(k) clearance for ASTROGLIDE BRAND WARMING LIQUID PERSONA..., manufactured by Biofilm, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K041432 · Biofilm, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
186d
Days
Class 2
Risk

K041432 is an FDA 510(k) clearance for the ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on November 30, 2004 after a review of 186 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 Biofilm, Inc. devices

FDA 510(k) Submission Details - K041432

510(k) Number K041432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date November 30, 2004
Days to Decision 186 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 160d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K041432.
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
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000