510K Summary FDA Advisory No.2021 1897 Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product RITE CARE PERSONAL LUBRICANT WATER SOLUBLE LUBRICATING GEL Food and Drug Administration Records processed under FOIA request 2018 4101; Released on 02 27 2019 Questions? Contact FDA CDRH OCE DID at CDRH FOISTATUS@fda United States Food and Drug Administration (FDA) Medical Device Classification System Does Lube Require FDA Approval? (And Ones That Are) PERSONAL LUBRICANTS: CLASS II MEDICAL DEVICES