HOW THE FDA CLASSIFIES PERSONAL LUBRICANTS AND WHAT IS AN FDA 510(K)? FDA Advisory No.2021 1504 Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products Food and Drug Administration United States Food and Drug Administration (FDA) Medical Device Classification System K Y Ultragel Premium Water based Personal Lubricant 1.5 oz, 1.5 fl oz Smith's Food and Drug FDA Approved : Lube : Target FDA Approved : Lube : Target