Lubricant, Personal
FDA product code NUC · Class II (moderate risk) · 21 CFR 884.5300 · Obstetrics/Gynecology
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
248510(k) clearances
0PMA approvals
7recalls
Manufacturers
- United Consortium 14
- Biofilm, Inc. 13
- CC Wellness, LLC 10
- Rb Health (Us), LLC 9
- Church & Dwight Co., Inc. 8
- Good Clean Love, Inc. 7
- Pjur Group Luxembourg S.A. 7
- Reckitt Benckiser, LLC 6
- Mcneil-Ppc, Inc. 5
- Ssl Americas, Inc. 5
- Ansell Healthcare Products LLC 4
- Combe, Inc. 3
- Fidia Farmaceutici S.P.A. 3
- Westridge Laboratories, Inc. 3
- Pharmapac, LLC 3
- Trigg Laboratories, Inc. 3
- Qualis, Inc. 3
- Hathor Professional Skincare , Ltd. 3
- Armkel, LLC 2
- Sheffield Laboratories, Div. of Faria Limited, LLC 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
| K253983 | Water-based lubricantNUC · Traditional | Guangzhou Haoyimai Trading Co., Ltd. | 03/06/2026SE |
| K251011 | Chiavaye Personal MoisturizerNUC · Traditional | Unipack, LLC | 12/19/2025SE |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml…NUC · Traditional | Foshan Pingchuang Medical Technology Co., Ltd. | 12/15/2025SE |
| K250488 | Cerynë Intimate CareNUC · Traditional | Ansella Therapeutics | 12/12/2025SE |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel…NUC · Traditional | Shenzhen Yongquan Medical Devices Co., Ltd. | 09/09/2025SE |
| K250142 | Water-based LubricantNUC · Traditional | Global Protection Corp. | 08/08/2025SE |
| K243972 | Plain Water-based LubricantNUC · Traditional | Global Protection Corp. | 08/08/2025SE |
| K242712 | LubriZenzsNUC · Traditional | Sk Zen, LLC | 06/04/2025SE |
| K243107 | Water Solubility Human Body LubricantNUC · Traditional | Dongguan Yanxuan Biotechnology Co., Ltd. | 05/09/2025SE |
| K250629 | Sutil Rich Personal LubricantNUC · Traditional | Hathor Professional Skincare , Ltd. | 05/02/2025SE |
| K242958 | Joylux Intimacy Gel (PG3100)NUC · Traditional | Joylux, Inc. | 03/20/2025SE |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…NUC · Traditional | Hathor Professional Skincare , Ltd. | 01/21/2025SE |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal LubricantNUC · Traditional | Project Chemistry, Inc. | 12/06/2024SE |
| K240745 | ID Free Personal LubricantNUC · Traditional | Westridge Laboratories, Inc. | 09/27/2024SE |
| K242162 | Coconut HybridNUC · Traditional | Good Clean Love, Inc. | 09/19/2024SE |
| K240081 | Human LubricantNUC · Traditional | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 08/16/2024SE |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantNUC · Traditional | Select Labs, LLC | 06/07/2024SE |
| K232040 | GynatrofNUC · Traditional | Tyros Biopharma, Inc. | 03/01/2024SE |
| K231794 | Elegant Advanced CompHortNUC · Traditional | Viramal Limited | 12/22/2023SE |
| K232093 | Woo More Play Coconut Love OilNUC · Traditional | Woo Essentials, Inc. | 12/01/2023SE |
| K232091 | JO Coconut Hybrid Cooling Personal LubricantNUC · Traditional | CC Wellness, LLC | 10/22/2023SE |
| K232090 | JO Coconut Hybrid Warming Personal LubricantNUC · Traditional | CC Wellness, LLC | 10/11/2023SE |
| K223519 | Carex Hybrid Personal LubricantNUC · Abbreviated | Karex Industries Sdn. Bhd. | 08/11/2023SE |
| K221137 | Play and Joy Water-Based LubricantNUC · Traditional | Innovemed Bio-Tech Co., Ltd. | 07/11/2023SE |
| K220646 | Play&Joy InvisiLube Lubricant CapsuleNUC · Traditional | Innovemed Bio-Tech Co., Ltd. | 07/10/2023SE |
| K230518 | HydraDose Vaginal SuppositoriesNUC · Traditional | MD Labs, LLC | 06/23/2023SE |
| K230781 | Belle SensilubeNUC · Traditional | Rb Health (Us), LLC | 06/20/2023SE |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant…NUC · Traditional | CC Wellness, LLC | 05/08/2023SE |
| K220226 | X-Y Lubricating JellyNUC · Traditional | R&R Medical Corporation, Ltd. | 03/28/2023SE |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineNUC · Traditional | Rb Health (Us), LLC | 03/07/2023SE |
| K222567 | Playground For All Love SeshNUC · Traditional | Playground For All | 01/30/2023SE |
| K222175 | Bloomi Delight Oil-Based Personal LubricantNUC · Traditional | The Bloomi Inc.. | 11/15/2022SE |
| K220273 | Onetouch Non-paraben Lubricant GelNUC · Traditional | Thai Nippon Rubber Industry Public Company… | 10/21/2022SE |
| K221243 | OFNat Lubricant (L15)NUC · Traditional | Suretex Limited | 09/30/2022SE |
| K221829 | Wet Flavored Personal LubricantsNUC · Traditional | Trigg Laboratories, Inc. | 09/23/2022SE |
| K221908 | JO CUMPLAY Personal LubricantNUC · Traditional | CC Wellness, LLC | 09/20/2022SE |
| K221328 | Bloomi Smooth Water Based LubricantNUC · Traditional | The Bloomi Inc.. | 08/04/2022SE |
| K220534 | Wet Essential95 Personal LubricantNUC · Traditional | Trigg Laboratories, Inc. | 07/07/2022SE |
| K221036 | Astroglide WarmingNUC · Traditional | Biofilm, Inc. | 07/01/2022SE |
| K213220 | Revaree Plus Vaginal SuppositoriesNUC · Traditional | Farma-Derma S.R.L. | 06/21/2022SE |
| K220355 | Astroglide Ultra Gentle GelNUC · Traditional | Biofilm, Inc. | 05/26/2022SE |
| K220653 | Astroglide Glycerin & Paraben FreeNUC · Traditional | Biofilm, Inc. | 05/06/2022SE |
| K212260 | Sensuva Premium Silicone Personal LubricantNUC · Traditional | Valencia Naturals, Inc. | 04/13/2022SE |
| K213671 | Astroglide Sensual Strawberry Personal LubricantNUC · Traditional | Biofilm, Inc. | 03/03/2022SE |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play…NUC · Traditional | Rb Health (Us) | 03/01/2022SE |
| K210095 | Playboy Premium Silicone LubricantNUC · Traditional | Thai Nippon Rubber Industry Public Company… | 11/23/2021SE |
| K212104 | Water-soluble Personal LubricantNUC · Traditional | Foshan Pingchuang Medical Technology Co., Ltd. | 11/18/2021SE |
| K212000 | MedleyNUC · Traditional | Good Clean Love, Inc. | 11/18/2021SE |
| K211998 | Desnuda ReflectNUC · Traditional | Good Clean Love, Inc. | 11/18/2021SE |
| K211967 | Sensual Massage, Ultra PureNUC · Traditional | Dreambrands, Inc. | 11/09/2021SE |
| K210857 | Personal LubricantNUC · Traditional | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | 09/24/2021SE |
| K201612 | Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5NUC · Traditional | Viramal Limited | 09/02/2021SE |
| K211088 | Grosz Play FeelNUC · Traditional | Rb Health (Us), LLC | 07/09/2021SE |
| K210814 | Coconu Water Based Personal LubricantNUC · Traditional | Coconu, LLC | 06/14/2021SE |
| K203818 | Replens Long-Lasting Vaginal MoisturizerNUC · Traditional | Church & Dwight Co., Inc. | 06/11/2021SE |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…NUC · Traditional | CC Wellness, LLC | 06/10/2021SE |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for…NUC · Traditional | CC Wellness, LLC | 06/10/2021SE |
| K202667 | Personal Lubricant JellyNUC · Traditional | Nantong Health & Beyond Hygienic Products, Inc. | 05/18/2021SE |
| K210242 | Astroglide X Silicone Personal LubricantNUC · Traditional | Biofilm, Inc. | 04/28/2021SE |
| K203654 | Solevy Co. LLC Water-Based Personal LubricantNUC · Traditional | Solevy Co., LLC | 04/19/2021SE |
| K203644 | Solevy Co. LLC Silicone Based Personal LubricantNUC · Traditional | Solevy Co., LLC | 04/19/2021SE |
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…NUC · Traditional | Pjur Group Luxembourg S.A. | 02/19/2021SE |
| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal…NUC · Traditional | Pjur Group Luxembourg S.A. | 01/21/2021SE |
| K201922 | Trophikos Vaginal MoisturizerNUC · Traditional | Trophikos, LLC | 01/14/2021SE |
| K202017 | Passion Natural Water Based LubricantNUC · Traditional | Xr, LLC | 01/08/2021SE |
| K203257 | LUBi Water Based Personal LubricantNUC · Traditional | Boya Biotechnology Co., Ltd. | 12/23/2020SE |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glideNUC · Traditional | Pjur Group Luxembourg S.A. | 12/17/2020SE |
| K193444 | Vagisan MoistCream CremolumNUC · Traditional | Dr. August Wolff GmbH & Co. KG Arzneimittel | 12/04/2020SE |
| K200239 | Astroglide Organix GelNUC · Traditional | Biofilm, Inc. | 11/13/2020SE |
| K200098 | VagiVital AktivgelNUC · Traditional | Peptonic Medical AB | 11/10/2020SE |
| K200114 | Astroglide Organix LiquidNUC · Traditional | Biofilm, Inc. | 10/13/2020SE |
| K201186 | KY Grosz JellyNUC · Traditional | Rb Health (Us), LLC | 07/30/2020SE |
| K200894 | Agape Cooling Personal LubricantNUC · Traditional | CC Wellness, LLC | 07/02/2020SE |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantNUC · Traditional | CC Wellness, LLC | 06/03/2020SE |
| K192779 | Bunny Wax Personal LubricantNUC · Traditional | Reoxcyn, LLC | 06/02/2020SE |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One WarmingNUC · Traditional | CC Wellness, LLC | 05/22/2020SE |
| K200208 | Agape Warming Personal LubricantNUC · Traditional | CC Wellness, LLC | 04/27/2020SE |
| K193032 | KY Grosz LiquidNUC · Traditional | Rb Health (Us), LLC | 04/20/2020SE |
| K192982 | KY Grosz UltraGelNUC · Traditional | Rb Health (Us), LLC | 04/14/2020SE |
| K191654 | SILICONE Personal LubricantNUC · Traditional | Bath Concept Cosmetics (Dongguan) Co., Ltd. | 04/14/2020SE |
| K193448 | BioNourish LubricantNUC · Traditional | Good Clean Love, Inc. | 03/12/2020SE |
| K192203 | JO for Him H2O Gel Original Personal LubricantNUC · Traditional | United Consortium | 02/10/2020SE |
| K191411 | Ah!Yes Ob Coco Personal LubricantNUC · Traditional | Bio-Tech Lubricants, Ltd. | 02/06/2020SE |
| K191052 | HyaloGYN Vaginal Moisturizing SuppositoriesNUC · Traditional | Fidia Farmaceutici S.P.A. | 01/09/2020SE |
| K190752 | SatisfaiteNUC · Traditional | Femmepharma Consumer Healthcare, LLC | 12/13/2019SE |
| K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva…NUC · Traditional | Valencia Naturals, Inc. | 11/19/2019SE |
| K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…NUC · Traditional | Trigg Laboratories, Inc. D/B/A Wet International | 10/11/2019SE |
| K190323 | Aloe Glide LubricantNUC · Traditional | Desert Harvest, Inc. | 09/25/2019SE |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY…NUC · Traditional | United Consortium | 09/18/2019SE |
| K191214 | JO Premium Jelly Original Personal LubricantNUC · Traditional | United Consortium | 08/01/2019SE |
| K190150 | Sage 2-in-1 Personal Lubricant and MoisturizerNUC · Traditional | Fairhaven Health, LLC | 07/16/2019SE |
| K183050 | GLISSANT Intimate LubricantNUC · Traditional | Vjuvenate, LLC | 07/08/2019SE |
| K183505 | KY Banksy MoistureNUC · Traditional | Rb Health (Us), LLC | 05/17/2019SE |
| K182100 | Smile Makers Personal LubricantNUC · Traditional | Lfbeauty (Thailand) Limited | 04/25/2019SE |
| K183584 | JO H2O Jelly Original Personal LubricantNUC · Traditional | United Consortium | 04/17/2019SE |
| K183302 | KY Banksy AloeNUC · Traditional | Rb Health (Us), LLC | 04/16/2019SE |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…NUC · Traditional | United Consortium | 03/04/2019SE |
| K180014 | Creme de La Femme Feminine LubricantNUC · Traditional | Cewal, Inc. Dba Premiere Enterprises | 12/21/2018SE |
| K180828 | Natureplex Warm Touch Warming JellyNUC · Traditional | Natureplex, LLC | 12/20/2018SE |
| K182027 | Wet Organics Personal LubricantNUC · Traditional | Trigg Laboratories Dba Wet International | 11/21/2018SE |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…NUC · Traditional | United Consortium | 11/14/2018SE |
| K181078 | The Sex GelNUC · Traditional | Necessaire, Inc. | 09/10/2018SE |
| K181408 | JO Classic Hybrid Personal LubricantNUC · Traditional | United Consortium | 08/27/2018SE |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)NUC · Traditional | Church & Dwight Co., Inc. | 08/01/2018SE |
| K180923 | Personal Lubricating JellyNUC · Traditional | Perrigo New York, Inc. | 07/09/2018SE |
| K180712 | Coconut Infused Hybrid Personal LubricantNUC · Traditional | United Consortium | 06/06/2018SE |
| K180136 | BioNude LubricantNUC · Traditional | Good Clean Love, Inc. | 06/01/2018SE |
| K180219 | JO H2O Flavored Personal LubricantsNUC · Traditional | United Consortium | 04/20/2018SE |
| K172306 | SuperSlyde Personal LubricantNUC · Traditional | Icm Pharma Pte, Ltd. | 04/19/2018SE |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONENUC · Traditional | United Consortium | 04/09/2018SE |
| K171516 | Flip LubeNUC · Traditional | Imquest Biosciences, Inc. | 02/05/2018SE |
| K173504 | K-Y SiliconeNUC · Traditional | Reckitt Benckiser, LLC | 01/12/2018SE |
| K172473 | LifeStyles® SKYN® Intimate Moments Personal LubricantNUC · Traditional | Sxwell USA, LLC | 12/15/2017SE |
| K170797 | wettrust D2careNUC · Traditional | Wettrust Korea Co., Ltd. | 12/06/2017SE |
| K171044 | Climax Personal LubricantNUC · Traditional | Wsm Investment, LLC, Dba Topco Sales | 11/21/2017SE |
| K172447 | JO Gelato Flavored Personal LubricantsNUC · Traditional | United Consortium | 10/31/2017SE |
| K163674 | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens…NUC · Traditional | Neo Cosmetique | 09/22/2017SE |
| K171730 | FuckWaterNUC · Traditional | Non-Friction Products, Inc. | 09/07/2017SE |
| K171985 | Astroglide O Oil Personal Lubricant & Massage OilNUC · Traditional | Biofilm, Inc. | 08/30/2017SE |
| K171855 | External Moisturizing GelNUC · Special | Combe Incorporated | 07/21/2017SE |
| K171021 | JO Agapé Personal LubricantNUC · Traditional | United Consortium | 07/18/2017SE |
| K162569 | YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal…NUC · Traditional | Biotech Lubricants, Ltd. | 06/09/2017SE |
| K162207 | Restore Moisturizing Vaginal LubricantNUC · Traditional | Good Clean Love | 05/04/2017SE |
| K162235 | Luvena Vaginal Moisturizer & LubricantNUC · Traditional | Laclede, Inc. | 03/24/2017SE |
| K163395 | Astroglide Diamond Silicone Gel Personal LubricantNUC · Traditional | Biofilm, Inc. | 02/10/2017SE |
| K151857 | Love Alchemy's Love LotionNUC · Traditional | Love Alchemy, LLC | 01/09/2017SE |
| K161585 | Mano and Mano Personal LubricantNUC · Traditional | Mano and Mano Proprietary Limited | 09/06/2016SE |
| K161544 | Trojan Chain Reaction Personal LubricantNUC · Traditional | Church & Dwight Co., Inc. | 08/31/2016SE |
| K161385 | Just Like Me Personal LubricantNUC · Traditional | Wtfn-Dba Classic Erotica/Holiday Products | 08/17/2016SE |
| K152671 | Pulse Aloe-ahhNUC · Traditional | Toaster Labs, Inc. | 07/11/2016SE |
| K152628 | Pulse H20h!NUC · Traditional | Toaster Labs, Inc. | 07/11/2016SE |
| K153372 | Repagyn vaginal suppositoriesNUC · Traditional | Farma-Derma S.R.L. | 06/30/2016SE |
| K160763 | ally Liquid Personal LubricantNUC · Traditional | Private Label Production, LLC | 06/29/2016SE |
| K160717 | ally Warming Liquid Personal LubricantNUC · Traditional | Private Label Production, LLC | 06/14/2016SE |
| K152918 | Gun Oil, Pink, Gun Oil H2O, Pink WaterNUC · Traditional | Empowered Products, Inc. | 06/02/2016SE |
| K152507 | Dr. Wolff Vagisan Moisturising CreamNUC · Traditional | Dr. August Wolff GmbH & Co. KG Arzeimittel | 05/20/2016SE |
| K160211 | Wet Original Personal LubricantNUC · Traditional | Trigg Laboratories D/B/A Wet International | 04/27/2016SE |
| K152646 | Sylk Personal LubricantNUC · Traditional | Toro Management, LLC Dba Sylk | 03/11/2016SE |
| K152168 | Love Liquid Personal LubricantNUC · Traditional | The Kama Sutra Company | 02/05/2016SE |
| K151884 | K-Y Marilyn Pleasure GelNUC · Traditional | Reckitt Benckiser, LLC | 01/11/2016SE |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal LubricantNUC · Traditional | Laclede, Inc. | 12/29/2015SE |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon VanillaNUC · Traditional | Good Clean Love, Inc. | 11/19/2015SE |
| K150743 | Water Based Personal Lubricant with FlavoursNUC · Abbreviated | Karex Industries Sdn. Bhd. | 11/12/2015SE |
| K150397 | Divine 9NUC · Traditional | Carrashield Labs, Inc. | 11/09/2015SE |
| K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss…NUC · Traditional | Package Solutions, LLC | 10/20/2015SE |
| K151647 | UberlubeNUC · Traditional | Uberlube, LLC | 09/23/2015SE |
| K143349 | GynomunalNUC · Traditional | Polichem S.A | 09/16/2015SE |
| K150883 | HyaloGYN Vaginal Hydrating GelNUC · Traditional | Fidia Farmaceutici S.P.A. | 09/01/2015SE |
| K143529 | UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal MoisturizerNUC · Traditional | Medline Industries, Inc. | 08/21/2015SE |
| K143532 | Durex SiliconeNUC · Traditional | Reckitt Benckiser, LLC | 07/31/2015SE |
| K142790 | OneTouch Lubricant GelNUC · Traditional | Thai Nippon Rubber Industry Co., Ltd. | 07/30/2015SE |
| K142726 | O Glide Personal LubricantNUC · Traditional | Grafenberg Labs | 07/24/2015SE |
| K150886 | Trojan Riviera Personal LubricantNUC · Traditional | Church & Dwight Co., Inc. | 07/20/2015SE |
| K143322 | Medline Natural Lubricating LiquidNUC · Traditional | Medline Industries, Inc. | 07/20/2015SE |
| K150480 | JO H20 Water Based Personal LubricantNUC · Traditional | United Consortium, Inc. | 07/08/2015SE |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantNUC · Traditional | Reckitt Benckiser | 05/20/2015SE |
| K150615 | Vaginal Moisturizing GelNUC · Traditional | Combe Incorporated | 05/01/2015SE |
| K140506 | Joy Drops (TM) Natural Personal Lubricant GelNUC · Traditional | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 04/17/2015SE |
| K141913 | Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse Me!NUC · Traditional | Pjur Group Luxembourg S.A. | 04/06/2015SE |
| K141767 | Id Millennium, Id Moments SiliconeNUC · Traditional | Westridge Laboratories, Inc. | 03/09/2015SE |
| K150147 | Lubrigyn creamNUC · Special | Uniderm Farmaceutici Srl | 02/19/2015SE |
| K131643 | Durex Realfeel Pleasure Gel Personal LubricantNUC · Traditional | Reckitt Benckiser, LLC | 12/17/2014SE |
| K141718 | Internal Hydrating GelNUC · Traditional | Combe Incorporated | 11/13/2014SE |
| K140193 | Durex Embrace Personal LubricantNUC · Traditional | Reckitt Benckiser, LLC | 11/04/2014SE |
| K140590 | Astroglide Sensual StrawberryNUC · Traditional | Biofilm, Inc. | 10/30/2014SE |
| K140304 | Simply Slick Personal Lubricating LotionNUC · Traditional | Simply Solutions, LLC | 10/07/2014SE |
| K132772 | Lubrigyn CreamNUC · Traditional | Uniderm Farmaceutici Srl | 08/22/2014SE |
| K141581 | Astroglide NaturalNUC · Traditional | Biofilm, Inc. | 08/06/2014SE |
| K133336 | Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium…NUC · Traditional | Pjur Group Luxembourg S.A. | 07/24/2014SE |
| K141034 | Azul Personal LubricantNUC · Traditional | Church & Dwight Co., Inc. | 07/21/2014SE |
| K133233 | Pjur Original, Pjur Woman, Pjur Man Extreme GlideNUC · Traditional | Pjur Group Luxembourg S.A. | 07/18/2014SE |
| K132954 | Jo Premium Personal LubricantNUC · Traditional | United Consortium | 06/11/2014SE |
| K122061 | K-Y Brand LiquibeadsNUC · Traditional | Johnson & Johnson Healthcare Products | 11/08/2013SE |
| K131084 | Sasmar Original, Sasmar ClassicNUC · Traditional | Sasmar, Inc. | 09/13/2013SE |
| K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsNUC · Traditional | Seven Oaks Ranch, Inc. | 08/30/2013SE |
| K130012 | Wet Platinum Personal LubricantNUC · Traditional | Trigg Laboratories, Inc. | 08/22/2013SE |
| K130345 | Aqua Lube Natural Lubricant - Regular, WarmingNUC · Traditional | Mayer Laboratories, Inc. | 08/01/2013SE |
| K123427 | Nirvana D Personal Lubricant (TBD)NUC · Traditional | Church & Dwight Co., Inc. | 06/28/2013SE |
| K123770 | Warming Jelly Personal LubricantNUC · Traditional | Wisconsin Pharmacal Co., LLC | 04/09/2013SE |
| K122476 | Lifestyles Smooth 2-IN-1 Massage & LubricantNUC · Traditional | Ansell Healthcare Products, LLC | 03/07/2013SE |
| K122720 | Lifestyles Warm Lovin Personal LubricantNUC · Traditional | Ansell Healthcare Products, LLC | 02/22/2013SE |
| K122477 | Lifestyles Luxe Premium Personal LubricantNUC · Traditional | Ansell Healthcare Products, LLC | 02/19/2013SE |
| K122054 | Lifestyles Natural Personal LubricantNUC · Traditional | Ansell Healthcare Products, LLC | 02/14/2013SE |
| K112217 | Me Again(R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal…NUC · Traditional | Polichem S.A | 10/16/2012SE |
| K120706 | Nirvana a Personal LubricantNUC · Traditional | Church & Dwight Co., Inc. | 10/04/2012SE |
| K120751 | Nirvana B Personal LubricantNUC · Traditional | Church & Dwight Co., Inc. | 10/03/2012SE |
| K120650 | Poise Personal LubricantNUC · Traditional | Kimberly-Clark Corporation | 07/11/2012SE |
| K110690 | One Personal Lubricant (Silicone)NUC · Abbreviated | One | 03/28/2012SE |
| K110691 | One Personal Lubricant (Water Based)NUC · Abbreviated | One | 02/01/2012SE |
| K110325 | Aqua LubeNUC · Traditional | Mayer Laboratories, Inc. | 12/08/2011SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1547-2022 Class II | KY JELLY LUBRICANT 2 FL OZ, SKU 901443Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-0875-2013 Class II | KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the…This product is not cleared for marketing in the US. | Mc-NEIL-PPC, Inc. | 01/25/2013Terminated |
| Z-0874-2013 Class II | KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz…This product is not cleared for marketing in the US. | Mc-NEIL-PPC, Inc. | 01/25/2013Terminated |
| Z-0873-2013 Class II | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which…This product is not cleared for marketing in the US. | Mc-NEIL-PPC, Inc. | 01/25/2013Terminated |
| Z-2467-2012 Class II | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ…Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns… | Mc-NEIL-PPC, Inc. | 07/02/2012Terminated |
| Z-1904-2009 | ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended…Product was marketed without a 510(k). | Memphis Fertility Laboratory Inc | 07/10/2009Terminated |
| Z-0626-2009 | Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to…Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci). | INGfertility, LLC | 09/22/2008Terminated |