For all cross-border sellers aspiring to the North American market, FDA 510(k) certification is the "golden ticket" to entering the personal lubricant market. It is not only a mandatory regulatory requirement but also the key to unlocking consumer trust. On mainstream platforms like Amazon, products with FDA 510(k) certification often achieve higher exposure and conversion rates.
FDA 510(k) is a premarket notification for medium-risk medical devices (personal lubricants are classified as such) by the U.S. Food and Drug Administration. Obtaining this certification means that the product is "substantially equivalent" in safety and effectiveness to similar products already legally marketed in the U.S. This provides the most authoritative official endorsement of the product's quality. Consumers, when choosing, tend to purchase products with this certification because it represents compliance and safety. For sellers, possessing this certification not only allows for smooth listing but also serves as a core selling point in marketing, effectively enhancing the brand's professional image and establishing a competitive advantage.
Don't let certification become an obstacle to your success in North America. Pingchuang Medical has obtained complete US FDA 510(k) certification and can freely authorize its use to you. We provide you with a full set of compliance documents to help you easily handle platform reviews and make your products best-sellers in the North American market.
