Does lube need to be FDA approved

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FDA 510k approved silicone personal lubricant

FDA 510k approved silicone personal lubricant

In the United States, personal lubricants are considered medical devices by the Food and Drug Administration (FDA) when they are intended for use during sexual activity to supplement the body’s natural lubrication, moisturize, or ease discomfort. Silicone-based personal lubricants also under Class II medical devices, requiring FDA clearance through the 510(k) premarket notification process. This process ensures that the product …

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