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FDA 510 K medical clearance for vaginal lubricants: issues and answers

Krychman, M1

1: Southern California Center for Sexual Health and Survivorship Medicine Inc, United States

Introduction: Vaginal moisturizers and lubricants have become under greater scrutiny with the consumer awareness campaign that has focused on additives and potential chemical irritants or carcinogens in these products. Acid base status, osmolality, and chemical ingredients are now of paramount concern. Recently the FDA has requiring all products  have a Class II Medical Device 510(k) clearance. This 510(k) is a premarket submission, made directly to the FDA that has sufficient evidence to demonstrate that the lubricant/device is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. We conducted this survey to investigate whether a) consumers were aware if the lubricant they were using was 510K and b) to investigate if companies were actively marketing this clearance on their home consumer web-internet page.

Methods: We reviewed the official FDA site and retrieved information concerning 50 lubricants (30 water based; 20 silicone based products. In addition, also performed a systematic review of these products websites and surveyed whether or not they illustrated the concept of 510K/FDA clearance on their home page. In addition, we surveyed 50 consecutive patients in a sexual medicine clinic.

Results: A total of 50 lubricants (30 water; 20 silicone based products) were assessed. 50% (15/30) water based lubricants were deemed to be 510K cleared by the FDA whereas only 14% of those mentioned this designation on their website. Fifty percent of the silicone lubes (10/20) were 510 Cleared and only 5% of them mentioned it on their websites. Common terms found on the lubricant websites included: medical grade, all natural, organic, vegan friendly, no chemicals, non-irritating, medically approved, high quality formulated, infused with natural products, doctor approved. 96% of the woman were aware if their lubricant was 510K cleared. 96% of women (n=48) did have any concept of what the 510K clearance specified. One women felt that 510K clearance meant “uncovered by insurance” another felt it meant that “there were no adverse effects”

Discussion: Most women are unaware of the 510K designation nor are they familiar with its significance and meaning. They remain unaware of potentially caustic additives in their personal lubricants. There are many opportunities to improve lubricant education for women.


Work supported by industry: yes, by SYLK USA (industry funding only - investigator initiated and executed study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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