Cleared Traditional

K040428 - MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM

K040428 is an FDA 510(k) clearance for MULTIPLE EROZONE BODYGLIDE FLUID, manufactured by R & K International Cosmetics. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K040428 · R & K International Cosmetics · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
537d
Days
Class 2
Risk

K040428 is an FDA 510(k) clearance for the MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSI.... Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by R & K International Cosmetics (Washington, US). The FDA issued a Cleared decision on August 9, 2005 after a review of 537 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K040428

510(k) Number K040428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2004
Decision Date August 09, 2005
Days to Decision 537 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 161d · This submission: 537d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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 - NUC Lubricant, Personal

All 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K040428.
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K042958 · Ssl Americas, Inc. · Apr 2005
PERSONAL WARMING GEL
K050211 · Qualis, Inc. · Mar 2005
K040428 · MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM
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