Product Code: NUC
FDA class 2
21 CFR 884.5300
Lubricant, Personal
Obstetrics/Gynecology
The Personal Lubricant is a device intended for penile and/or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. The product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. It is an FDA Class 2 device regulated under 21 CFR 884.5300 in the Obstetrics/Gynecology specialty, with product code NUC, requiring 510(k) clearance. Third-party review is available. It does not carry implant or life-sustaining support designations.
510(k)s
231
FEI Numbers
117
Registration Numbers
117
Unique Applicants
143
Years Active
25
Basic Information
- Product Code
- NUC
- Device Class
- FDA class 2
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
Definition
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 231 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242712 | LubriZenzs | Jun 04, 2025 | Substantially Equivalent | SK Zen LLC |
| K243107 | Water Solubility Human Body Lubricant | May 09, 2025 | Substantially Equivalent | Dongguan Yanxuan Biotechnology Co., Ltd. |
| K250629 | Sutil Rich Personal Lubricant | May 02, 2025 | Substantially Equivalent | Hathor Professional Skincare Ltd. |
| K242958 | Joylux Intimacy Gel (PG3100) | Mar 20, 2025 | Substantially Equivalent | Joylux, Inc |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Jan 21, 2025 | Substantially Equivalent | Hathor Professional Skincare Ltd. |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Dec 06, 2024 | Substantially Equivalent | Project Chemistry, Inc. |
| K240745 | ID Free Personal Lubricant | Sep 27, 2024 | Substantially Equivalent | Westridge Laboratories, Inc. |
| K242162 | Coconut Hybrid | Sep 19, 2024 | Substantially Equivalent | Good Clean Love, Inc. |
| K240081 | Human Lubricant | Aug 16, 2024 | Substantially Equivalent | Jiangxi Wulinxiang Biological Technology Co., Ltd. |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Jun 07, 2024 | Substantially Equivalent | Select Labs, LLC |
| K232040 | Gynatrof | Mar 01, 2024 | Substantially Equivalent | Tyros Biopharma Inc. |
| K231794 | Elegant Advanced CompHort | Dec 22, 2023 | Substantially Equivalent | Viramal Limited |
| K232093 | Woo More Play Coconut Love Oil | Dec 01, 2023 | Substantially Equivalent | Woo Essentials, Inc. |
| K232091 | JO Coconut Hybrid Cooling Personal Lubricant | Oct 22, 2023 | Substantially Equivalent | CC Wellness LLC |
| K232090 | JO Coconut Hybrid Warming Personal Lubricant | Oct 11, 2023 | Substantially Equivalent | CC Wellness LLC |
| K223519 | Carex Hybrid Personal Lubricant | Aug 11, 2023 | Substantially Equivalent | Karex Industries Sdn. Bhd. |
| K221137 | Play and Joy Water-Based Lubricant | Jul 11, 2023 | Substantially Equivalent | InnoveMed Bio-tech Co., Ltd. |
| K220646 | Play&Joy InvisiLube Lubricant Capsule | Jul 10, 2023 | Substantially Equivalent | InnoveMed Bio-tech Co., Ltd. |
| K230518 | HydraDose Vaginal Suppositories | Jun 23, 2023 | Substantially Equivalent | MD Labs LLC |
| K230781 | Belle Sensilube | Jun 20, 2023 | Substantially Equivalent | RB Health (US) LLC |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | May 08, 2023 | Substantially Equivalent | CC Wellness LLC |
| K220226 | X-Y Lubricating Jelly | Mar 28, 2023 | Substantially Equivalent | R&R Medical Corporation Ltd |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | Mar 07, 2023 | Substantially Equivalent | RB Health (US) LLC |
| K222567 | Playground For All Love Sesh | Jan 30, 2023 | Substantially Equivalent | Playground For All |
| K222175 | Bloomi Delight Oil-Based Personal Lubricant | Nov 15, 2022 | Substantially Equivalent | The Bloomi Inc.. |
| K220273 | Onetouch Non-paraben Lubricant Gel | Oct 21, 2022 | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. |
| K221243 | OFNat Lubricant (L15) | Sep 30, 2022 | Substantially Equivalent | Suretex Limited |
| K221829 | Wet Flavored Personal Lubricants | Sep 23, 2022 | Substantially Equivalent | Trigg Laboratories, Inc. |
| K221908 | JO CUMPLAY Personal Lubricant | Sep 20, 2022 | Substantially Equivalent | CC Wellness LLC |
| K221328 | Bloomi Smooth Water Based Lubricant | Aug 04, 2022 | Substantially Equivalent | The Bloomi Inc.. |
| K220534 | Wet Essential95 Personal Lubricant | Jul 07, 2022 | Substantially Equivalent | Trigg Laboratories, Inc. |
| K221036 | Astroglide Warming | Jul 01, 2022 | Substantially Equivalent | BioFilm Inc. |
| K213220 | Revaree Plus Vaginal Suppositories | Jun 21, 2022 | Substantially Equivalent | Farma-Derma S.R.L. |
| K220355 | Astroglide Ultra Gentle Gel | May 26, 2022 | Substantially Equivalent | BioFilm Inc. |
| K220653 | Astroglide Glycerin & Paraben Free | May 06, 2022 | Substantially Equivalent | BioFilm Inc. |
| K212260 | Sensuva Premium Silicone Personal Lubricant | Apr 13, 2022 | Substantially Equivalent | Valencia Naturals, Inc |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Mar 03, 2022 | Substantially Equivalent | BioFilm Inc. |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | Mar 01, 2022 | Substantially Equivalent | RB Health (US) |
| K210095 | Playboy Premium Silicone Lubricant | Nov 23, 2021 | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited |
| K212104 | Water-soluble Personal Lubricant | Nov 18, 2021 | Substantially Equivalent | Foshan PingChuang Medical Technology Co., Ltd. |
| K212000 | Medley | Nov 18, 2021 | Substantially Equivalent | Good Clean Love, Inc. |
| K211998 | Desnuda Reflect | Nov 18, 2021 | Substantially Equivalent | Good Clean Love, Inc. |
| K211967 | Sensual Massage, Ultra Pure | Nov 09, 2021 | Substantially Equivalent | Dreambrands, Inc. |
| K210857 | Personal Lubricant | Sep 24, 2021 | Substantially Equivalent | Shenzhen Huanqiu Xuebao Technology Co., Ltd. |
| K201612 | Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 | Sep 02, 2021 | Substantially Equivalent | Viramal Limited |
| K211088 | Grosz Play Feel | Jul 09, 2021 | Substantially Equivalent | RB Health (US) LLC |
| K210814 | Coconu Water Based Personal Lubricant | Jun 14, 2021 | Substantially Equivalent | Coconu, LLC. |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | Jun 11, 2021 | Substantially Equivalent | Church & Dwight Co., Inc |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit | Jun 10, 2021 | Substantially Equivalent | CC Wellness LLC |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two | Jun 10, 2021 | Substantially Equivalent | CC Wellness LLC |
| K202667 | Personal Lubricant Jelly | May 18, 2021 | Substantially Equivalent | Nantong Health & Beyond Hygienic Products Inc. |
| K210242 | Astroglide X Silicone Personal Lubricant | Apr 28, 2021 | Substantially Equivalent | BioFilm Inc. |
| K203654 | Solevy Co. LLC Water-Based Personal Lubricant | Apr 19, 2021 | Substantially Equivalent | Solevy Co. LLC |
| K203644 | Solevy Co. LLC Silicone Based Personal Lubricant | Apr 19, 2021 | Substantially Equivalent | Solevy Co. LLC |
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur | Feb 19, 2021 | Substantially Equivalent | pjur group Luxembourg SA |
| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 | Jan 21, 2021 | Substantially Equivalent | pjur group Luxembourg SA |
| K201922 | Trophikos Vaginal Moisturizer | Jan 14, 2021 | Substantially Equivalent | Trophikos, LLC |
| K202017 | Passion Natural Water Based Lubricant | Jan 08, 2021 | Substantially Equivalent | XR LLC |
| K203257 | LUBi Water Based Personal Lubricant | Dec 23, 2020 | Substantially Equivalent | Boya Biotechnology Co., Ltd. |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | Dec 17, 2020 | Substantially Equivalent | pjur group Luxembourg SA |
| K193444 | Vagisan MoistCream Cremolum | Dec 04, 2020 | Substantially Equivalent | Dr. August Wolff GmbH & Co. KG Arzneimittel |
| K200239 | Astroglide Organix Gel | Nov 13, 2020 | Substantially Equivalent | BioFilm Inc. |
| K200098 | VagiVital Aktivgel | Nov 10, 2020 | Substantially Equivalent | Peptonic Medical AB |
| K200114 | Astroglide Organix Liquid | Oct 13, 2020 | Substantially Equivalent | BioFilm Inc |
| K201186 | KY Grosz Jelly | Jul 30, 2020 | Substantially Equivalent | RB Health (US) LLC |
| K200894 | Agape Cooling Personal Lubricant | Jul 02, 2020 | Substantially Equivalent | CC Wellness LLC |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | Jun 03, 2020 | Substantially Equivalent | CC Wellness LLC |
| K192779 | Bunny Wax Personal Lubricant | Jun 02, 2020 | Substantially Equivalent | Reoxcyn, LLC |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming | May 22, 2020 | Substantially Equivalent | CC Wellness LLC |
| K200208 | Agape Warming Personal Lubricant | Apr 27, 2020 | Substantially Equivalent | CC Wellness LLC |
| K193032 | KY Grosz Liquid | Apr 20, 2020 | Substantially Equivalent | RB Health (US) LLC |
| K192982 | KY Grosz UltraGel | Apr 14, 2020 | Substantially Equivalent | RB Health (US) LLC |
| K191654 | SILICONE Personal Lubricant | Apr 14, 2020 | Substantially Equivalent | Bath Concept Cosmetics (Dongguan) Co., Ltd |
| K193448 | BioNourish Lubricant | Mar 12, 2020 | Substantially Equivalent | Good Clean Love, Inc. |
| K192203 | JO for Him H2O Gel Original Personal Lubricant | Feb 10, 2020 | Substantially Equivalent | United Consortium |
| K191411 | Ah!Yes Ob Coco Personal Lubricant | Feb 06, 2020 | Substantially Equivalent | Bio-Tech Lubricants Ltd |
| K191052 | HyaloGYN Vaginal Moisturizing Suppositories | Jan 09, 2020 | Substantially Equivalent | Fidia Farmaceutici S.p.A |
| K190752 | Satisfaite | Dec 13, 2019 | Substantially Equivalent | FemmePharma Consumer Healthcare, LLC |
| K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, | Nov 19, 2019 | Substantially Equivalent | Valencia Naturals Inc. |
| K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) | Oct 11, 2019 | Substantially Equivalent | Trigg Laboratories, Inc. D/B/A Wet International |
| K190323 | Aloe Glide Lubricant | Sep 25, 2019 | Substantially Equivalent | Desert Harvest, Inc |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant | Sep 18, 2019 | Substantially Equivalent | United Consortium |
| K191214 | JO Premium Jelly Original Personal Lubricant | Aug 01, 2019 | Substantially Equivalent | United Consortium |
| K190150 | Sage 2-in-1 Personal Lubricant and Moisturizer | Jul 16, 2019 | Substantially Equivalent | Fairhaven Health, LLC |
| K183050 | GLISSANT Intimate Lubricant | Jul 08, 2019 | Substantially Equivalent | Vjuvenate, LLC |
| K183505 | KY Banksy Moisture | May 17, 2019 | Substantially Equivalent | RB Health (US) LLC |
| K182100 | Smile Makers Personal Lubricant | Apr 25, 2019 | Substantially Equivalent | LFBeauty (Thailand) Limited |
| K183584 | JO H2O Jelly Original Personal Lubricant | Apr 17, 2019 | Substantially Equivalent | United Consortium |
| K183302 | KY Banksy Aloe | Apr 16, 2019 | Substantially Equivalent | RB Health (US) LLC |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant | Mar 04, 2019 | Substantially Equivalent | United Consortium |
| K180014 | Creme de La Femme Feminine Lubricant | Dec 21, 2018 | Substantially Equivalent | Cewal, Inc. dba Premiere Enterprises |
| K180828 | Natureplex Warm Touch Warming Jelly | Dec 20, 2018 | Substantially Equivalent | Natureplex, LLC |
| K182027 | Wet Organics Personal Lubricant | Nov 21, 2018 | Substantially Equivalent | Trigg Laboratories DBA Wet International |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | Nov 14, 2018 | Substantially Equivalent | United Consortium |
| K181078 | The Sex Gel | Sep 10, 2018 | Substantially Equivalent | Necessaire, Inc. |
| K181408 | JO Classic Hybrid Personal Lubricant | Aug 27, 2018 | Substantially Equivalent | United Consortium |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | Aug 01, 2018 | Substantially Equivalent | Church & Dwight Co., Inc |
| K180923 | Personal Lubricating Jelly | Jul 09, 2018 | Substantially Equivalent | Perrigo New York, Inc. |
| K180712 | Coconut Infused Hybrid Personal Lubricant | Jun 06, 2018 | Substantially Equivalent | United Consortium |
| K180136 | BioNude Lubricant | Jun 01, 2018 | Substantially Equivalent | Good Clean Love, Inc. |
| K180219 | JO H2O Flavored Personal Lubricants | Apr 20, 2018 | Substantially Equivalent | United Consortium |
| K172306 | SuperSlyde Personal Lubricant | Apr 19, 2018 | Substantially Equivalent | ICM Pharma Pte Ltd |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONE | Apr 09, 2018 | Substantially Equivalent | United Consortium |
| K171516 | Flip Lube | Feb 05, 2018 | Substantially Equivalent | Imquest Biosciences Inc. |
| K173504 | K-Y Silicone | Jan 12, 2018 | Substantially Equivalent | Reckitt Benckiser LLC |
| K172473 | LifeStyles® SKYN® Intimate Moments Personal Lubricant | Dec 15, 2017 | Substantially Equivalent | SXWELL USA LLC |
| K170797 | wettrust D2care | Dec 06, 2017 | Substantially Equivalent | Wettrust Korea Co., Ltd. |
| K171044 | Climax Personal Lubricant | Nov 21, 2017 | Substantially Equivalent | WSM Investment LLC, dba Topco Sales |
| K172447 | JO Gelato Flavored Personal Lubricants | Oct 31, 2017 | Substantially Equivalent | United Consortium |
| K163674 | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry | Sep 22, 2017 | Substantially Equivalent | NEO COSMETIQUE |
| K171730 | FuckWater | Sep 07, 2017 | Substantially Equivalent | Non-Friction Products Inc. |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Aug 30, 2017 | Substantially Equivalent | BioFilm Inc. |
| K171855 | External Moisturizing Gel | Jul 21, 2017 | Substantially Equivalent | Combe Incorporated |
| K171021 | JO Agapé Personal Lubricant | Jul 18, 2017 | Substantially Equivalent | United Consortium |
| K162569 | YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer | Jun 09, 2017 | Substantially Equivalent | BIOTECH LUBRICANTS LTD |
| K162207 | Restore Moisturizing Vaginal Lubricant | May 04, 2017 | Substantially Equivalent | Good Clean Love |
| K162235 | LUVENA VAGINAL MOISTURIZER & LUBRICANT | Mar 24, 2017 | Substantially Equivalent | LACLEDE, INC. |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Feb 10, 2017 | Substantially Equivalent | BioFilm, Inc. |
| K151857 | Love Alchemy's Love Lotion | Jan 09, 2017 | Substantially Equivalent | LOVE ALCHEMY LLC |
| K161585 | Mano and Mano Personal Lubricant | Sep 06, 2016 | Substantially Equivalent | Mano and Mano Proprietary Limited |
| K161544 | Trojan Chain Reaction Personal Lubricant | Aug 31, 2016 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K161385 | Just Like Me Personal Lubricant | Aug 17, 2016 | Substantially Equivalent | WTFN-dba Classic Erotica/Holiday Products |
| K152671 | Pulse Aloe-ahh | Jul 11, 2016 | Substantially Equivalent | TOASTER LABS, INC |
| K152628 | Pulse H20h! | Jul 11, 2016 | Substantially Equivalent | TOASTER LABS, INC |
| K153372 | Repagyn vaginal suppositories | Jun 30, 2016 | Substantially Equivalent | FARMA-DERMA S.R.L. |
| K160763 | ally Liquid Personal Lubricant | Jun 29, 2016 | Substantially Equivalent | GUY & O'NEILL, INC. |
| K160717 | ally Warming Liquid Personal Lubricant | Jun 14, 2016 | Substantially Equivalent | GUY & O'NEILL, INC. |
| K152918 | Gun Oil, Pink, Gun Oil H2O, Pink Water | Jun 02, 2016 | Substantially Equivalent | EMPOWERED PRODUCTS, INC. |
| K152507 | Dr. Wolff Vagisan Moisturising Cream | May 20, 2016 | Substantially Equivalent | DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL |
| K160211 | Wet Original Personal Lubricant | Apr 27, 2016 | Substantially Equivalent | TRIGG LABORATORIES D/B/A WET INTERNATIONAL |
| K152646 | SYLK PERSONAL LUBRICANT | Mar 11, 2016 | Substantially Equivalent | TORO MANAGEMENT LLC DBA SYLK |
| K152168 | Love Liquid Personal Lubricant | Feb 05, 2016 | Substantially Equivalent | The Kama Sutra Company |
| K151884 | K-Y Marilyn Pleasure Gel | Jan 11, 2016 | Substantially Equivalent | Reckitt Benckiser LLC |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | Dec 29, 2015 | Substantially Equivalent | LACLEDE, INC. |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla | Nov 19, 2015 | Substantially Equivalent | Good Clean Love, Inc. |
| K150743 | Water Based Personal Lubricant with Flavours | Nov 12, 2015 | Substantially Equivalent | KAREX INDUSTRIES SDN. BHD. |
| K150397 | Divine 9 | Nov 09, 2015 | Substantially Equivalent | CarraShield Labs, Inc. |
| K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant | Oct 20, 2015 | Substantially Equivalent | Package Solutions LLC |
| K151647 | Uberlube | Sep 23, 2015 | Substantially Equivalent | UBERLUBE LLC |
| K143349 | Gynomunal | Sep 16, 2015 | Substantially Equivalent | POLICHEM S.A. |
| K150883 | HyaloGYN Vaginal Hydrating Gel | Sep 01, 2015 | Substantially Equivalent | FIDIA FARMACEUTICI SPA |
| K143529 | UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer | Aug 21, 2015 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K143532 | Durex Silicone | Jul 31, 2015 | Substantially Equivalent | Reckitt Benckiser LLC |
| K142790 | OneTouch Lubricant Gel | Jul 30, 2015 | Substantially Equivalent | THAI NIPPON RUBBER INDUSTRY CO., LTD. |
| K142726 | O Glide Personal Lubricant | Jul 24, 2015 | Substantially Equivalent | Grafenberg Labs |
| K150886 | Trojan Riviera Personal Lubricant | Jul 20, 2015 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K143322 | Medline Natural Lubricating Liquid | Jul 20, 2015 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K150480 | JO H20 Water Based Personal Lubricant | Jul 08, 2015 | Substantially Equivalent | UNITED CONSORTIUM INC. |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | May 20, 2015 | Substantially Equivalent | RECKITT BENCKISER |
| K150615 | Vaginal Moisturizing Gel | May 01, 2015 | Substantially Equivalent | COMBE INCORPORATED |
| K140506 | JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL | Apr 17, 2015 | Substantially Equivalent | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
| K141913 | PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! | Apr 06, 2015 | Substantially Equivalent | PJUR GROUP LUXEMBOURG SA |
| K141767 | ID MILLENNIUM, ID MOMENTS SILICONE | Mar 09, 2015 | Substantially Equivalent | WESTRIDGE LABORATORIES, INC. |
| K150147 | Lubrigyn cream | Feb 19, 2015 | Substantially Equivalent | UNIDERM FARMACEUTICI SRL |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | Dec 17, 2014 | Substantially Equivalent | RECKITT BENCKISER, LLC |
| K141718 | INTERNAL HYDRATING GEL | Nov 13, 2014 | Substantially Equivalent | COMBE INCORPORATED |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | Nov 04, 2014 | Substantially Equivalent | RECKITT BENCKISER, LLC |
| K140590 | ASTROGLIDE SENSUAL STRAWBERRY | Oct 30, 2014 | Substantially Equivalent | BIOFILM, INC. |
| K140304 | SIMPLY SLICK PERSONAL LUBRICATING LOTION | Oct 07, 2014 | Substantially Equivalent | SIMPLY SOLUTIONS, LLC |
| K132772 | LUBRIGYN CREAM | Aug 22, 2014 | Substantially Equivalent | UNIDERM FARMACEUTICI SRL |
| K141581 | ASTROGLIDE NATURAL | Aug 06, 2014 | Substantially Equivalent | BIOFILM, INC. |
| K133336 | PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE | Jul 24, 2014 | Substantially Equivalent | PJUR GROUP,LUXEMBOURG S.A. |
| K141034 | AZUL PERSONAL LUBRICANT | Jul 21, 2014 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K133233 | PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE | Jul 18, 2014 | Substantially Equivalent | PJUR GROUP LUXEMBOURG SA |
| K132954 | JO PREMIUM PERSONAL LUBRICANT | Jun 11, 2014 | Substantially Equivalent | UNITED CONSORTIUM |
| K122061 | K-Y BRAND LIQUIBEADS | Nov 08, 2013 | Substantially Equivalent | JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
| K131084 | SASMAR ORIGINAL, SASMAR CLASSIC | Sep 13, 2013 | Substantially Equivalent | SASMAR INC |
| K124044 | ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS | Aug 30, 2013 | Substantially Equivalent | SEVEN OAKS RANCH, INC. |
| K130012 | WET PLATINUM PERSONAL LUBRICANT | Aug 22, 2013 | Substantially Equivalent | TRIGG LABORATORIES, INC. |
| K130345 | AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING | Aug 01, 2013 | Substantially Equivalent | MAYER LABORATORIES, INC. |
| K123427 | NIRVANA D PERSONAL LUBRICANT (TBD) | Jun 28, 2013 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K123770 | WARMING JELLY PERSONAL LUBRICANT | Apr 09, 2013 | Substantially Equivalent | WISCONSIN PHARMACAL CO., LLC |
| K122476 | LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT | Mar 07, 2013 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K122720 | LIFESTYLES WARM LOVIN PERSONAL LUBRICANT | Feb 22, 2013 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K122477 | LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT | Feb 19, 2013 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS LLC |
| K122054 | LIFESTYLES NATURAL PERSONAL LUBRICANT | Feb 14, 2013 | Substantially Equivalent | ANSELL HEALTHCARE PRODUCTS, LLC |
| K112217 | ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER | Oct 16, 2012 | Substantially Equivalent | POLICHEM S.A. |
| K120706 | NIRVANA A PERSONAL LUBRICANT | Oct 04, 2012 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K120751 | NIRVANA B PERSONAL LUBRICANT | Oct 03, 2012 | Substantially Equivalent | CHURCH & DWIGHT CO., INC. |
| K120650 | POISE PERSONAL LUBRICANT | Jul 11, 2012 | Substantially Equivalent | KIMBERLY-CLARK CORPORATION |
| K110690 | ONE PERSONAL LUBRICANT (SILICONE) | Mar 28, 2012 | Substantially Equivalent | ONE |
| K110691 | ONE PERSONAL LUBRICANT (WATER BASED) | Feb 01, 2012 | Substantially Equivalent | ONE |
| K110325 | AQUA LUBE | Dec 08, 2011 | Substantially Equivalent | MAYER LABORATORIES, INC. |
| K101585 | K-Y BRAND LONG LASTING VAGINAL MOISTURIZER | May 10, 2011 | Substantially Equivalent | JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR |
| K101241 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) | Aug 17, 2010 | Substantially Equivalent | LIL DRUG STORE PRODUCTS, INC. |
| K101098 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 | Aug 17, 2010 | Substantially Equivalent | LIL DRUG STORE PRODUCTS, INC. |
| K094039 | HYALO GYN | May 07, 2010 | Substantially Equivalent | FIDIA FARMACEUTICI SPA |
| K091298 | LUBREASE FEMALE LUBRICANT | Feb 24, 2010 | Substantially Equivalent | CURVES LIMITED |
| K091554 | PHARMAPAC PERSONAL LUBRICANT | Aug 07, 2009 | Substantially Equivalent | PHARMAPAC LLC |
| K080978 | WALGREEN'S PERSONAL LUBRICATING JELLY | Apr 23, 2009 | Substantially Equivalent | TOPCO SALES |
| K081236 | K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME | Sep 25, 2008 | Substantially Equivalent | MCNEIL-PPC, INC. |
| K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT | May 07, 2008 | Substantially Equivalent | SSL AMERICAS |
| K070587 | ELEGANCE WOMAN'S LUBRICANT | Apr 10, 2008 | Substantially Equivalent | JULIE WILLIAMS, PA-C |
| K071626 | DUREX PLAY SOFT & SENSUAL LUBRICANT | Apr 01, 2008 | Substantially Equivalent | SSL AMERICAS |
| K063385 | DUREX PLAY MASSAGE GEL LUBRICANT | Mar 10, 2008 | Substantially Equivalent | SSL AMERICAS, INC. |
| K072421 | K-Y BRAND YOURS+MINE | Mar 06, 2008 | Substantially Equivalent | MCNEIL-PPC, INC. |
| K072647 | GLYCERIN & PARABEN FREE ASTROGLIDE | Jan 25, 2008 | Substantially Equivalent | BIOFILM, INC. |
| K072360 | K-Y BRAND INTRIGUE INTENSE WARMING SENSATION | Dec 12, 2007 | Substantially Equivalent | MCNEIL-PPC, INC. |
| K070623 | PHARMAPAC LUBRICATING JELLY | Aug 31, 2007 | Substantially Equivalent | PHARMAPAC LLC |
| K062682 | CVS PERSONAL LUBRICANT AND MOISTURIZER | Apr 04, 2007 | Substantially Equivalent | LAKE CONSUMER PRODUCTS, INC. |
| K070545 | K-Y BRAND WARMING LIQUID | Mar 23, 2007 | Substantially Equivalent | PERSONAL PRODUCTS CO. |
| K062535 | K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING | Jan 26, 2007 | Substantially Equivalent | MCNEIL-PPC, INC. |
| K062796 | K-Y BRAND INTRIGUE | Dec 08, 2006 | Substantially Equivalent | PERSONAL PRODUCTS CO. |
| K061466 | INTIMOL | Dec 04, 2006 | Substantially Equivalent | DLC LABORATORIES, INC. |
| K051688 | FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS | Jul 12, 2006 | Substantially Equivalent | TRIMENSA PHARMACEUTICALS |
| K060098 | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS | Jun 08, 2006 | Substantially Equivalent | SSL AMERICAS, INC. |
| K060145 | FDS INTIMATE AND INTIMATE WARMING LUBRICANT | Apr 14, 2006 | Substantially Equivalent | ALBERTO-CULVER USA, INC. |
| K053397 | K-Y BRAND SENSUAL MIST | Feb 17, 2006 | Substantially Equivalent | MCNEIL-PPC, INC. |
| K051295 | I-D GLIDE | Feb 15, 2006 | Substantially Equivalent | WESTRIDGE LABORATORIES INC. |
| K052162 | SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT | Feb 06, 2006 | Substantially Equivalent | SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC |
| K052974 | WARMING LIQUID PERSONAL LUBRICANT | Dec 16, 2005 | Substantially Equivalent | PHARMAPAC LLC |
| K042915 | O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT | Aug 31, 2005 | Substantially Equivalent | O'MY PRODUCTS INCORPORATED |
| K040428 | MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM | Aug 09, 2005 | Substantially Equivalent | R & K INTERNATIONAL COSMETICS |
| K051668 | THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT | Jul 08, 2005 | Substantially Equivalent | GOODMARK USA, INC. |
| K042958 | DUREX PLAY TINGLING LUBRICANT | Apr 08, 2005 | Substantially Equivalent | SSL AMERICAS, INC. |
| K050212 | PERSONAL WARMING JELLY | Mar 17, 2005 | Substantially Equivalent | QUALIS, INC. |
| K050211 | PERSONAL WARMING GEL | Mar 17, 2005 | Substantially Equivalent | QUALIS, INC. |
| K041129 | PERSONAL LUBRICATING GEL | Sep 24, 2004 | Substantially Equivalent | QUALIS, INC. |
| K033776 | INSTEAD INTIMATE LUBRICANT | Jun 25, 2004 | Substantially Equivalent | INSTEAD, INC. |
| K040340 | K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT | Apr 28, 2004 | Substantially Equivalent | PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC |
| K040164 | K-Y BRAND WARMING JELLY PERSONAL LUBRICANT | Apr 05, 2004 | Substantially Equivalent | PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC |
| K021737 | REPHRESH VAGINAL GEL | Aug 26, 2002 | Substantially Equivalent | COLUMBIA LABORATORIES, INC. |
| K021492 | K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT | Aug 07, 2002 | Substantially Equivalent | PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. |
| K020827 | K-Y BRAND ULTRA GEL PERSONAL LUBRICANT | Jun 12, 2002 | Substantially Equivalent | PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. |
| K013433 | TROJAN PASSION BERRY GEL | Mar 05, 2002 | Substantially Equivalent | ARMKEL LLC |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 01, 2002 | Substantially Equivalent | ARMKEL LLC |
| K012203 | CLAY-PARK LABS, INC. - LUBRICATING JELLY | Aug 27, 2001 | Substantially Equivalent | CLAY-PARK LABS, INC. |
| K010199 | PJUR EROS WATER FORMULATION | Apr 05, 2001 | Substantially Equivalent | L.C.C. PJUR GROUP GERMANY |
| K010182 | VCF PERSONAL LUBRICANT | Mar 09, 2001 | Substantially Equivalent | APOTHECUS PHARMACEUTICAL CORP. |
| K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) | Mar 09, 2001 | Substantially Equivalent | BIOFILM, INC. |
| K001077 | LUBRIGEL PERSONAL LUBRICANT | Aug 02, 2000 | Substantially Equivalent | SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC |
FEI Numbers
This FDA classification entry is associated with 117 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 117 registration numbers. Click on an entry to view related FDA registrations.