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Durex Play™ Warmer™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.

This 510(k) summary for Durex Play Warmer™ personal lubricant does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are typically not required for Class II devices seeking substantial equivalence via the 510(k) pathway.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or meeting specific performance criteria through a standalone study.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: Composition and general characteristics.
• Intended Use: What the lubricant is designed for.
• Substantial Equivalence: Comparison to existing predicate devices (K-Y Jelly and AstroGlide) based on intended use, composition, and marketing.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or ground truth establishment.
• Expert involvement or adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithmic performance.
• Ground truth types or training set details.

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