Chrysalis Intelligence · Product Codes · NUC

NUC · Lubricant, Personal

Obstetrics/Gynecology · 93 clearances · 56 unique sponsors

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Device class
Class II
Regulation 884.5300
Total clearances
93
2020-01-09 → 2026-08-07
Last 12 months
14
Unique sponsors
56
Definition

What is Lubricant, Personal

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.
Classification details
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.5300
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
CC Wellness, LLC 10 0 2023-10-22
Rb Health (Us), LLC 7 0 2023-06-20
Biofilm, Inc. 7 0 2022-07-01
Good Clean Love, Inc. 4 0 2024-09-19
Pjur Group Luxembourg S.A. 4 1 2026-05-21
Hathor Professional Skincare , Ltd. 3 1 2026-06-09
Global Protection Corp. 2 0 2025-08-08
Solevy Co., LLC 2 0 2021-04-19
Trigg Laboratories, Inc. 2 0 2022-09-23
The Bloomi Inc.. 2 0 2022-11-15
Innovemed Bio-Tech Co., Ltd. 2 0 2023-07-11
Thai Nippon Rubber Industry Public Company Limited. 2 0 2022-10-21
Viramal Limited 2 0 2023-12-22
Foshan Pingchuang Medical Technology Co., Ltd. 2 1 2025-12-15
Farma-Derma S.R.L. 1 0 2022-06-21
Nantong Health & Beyond Hygienic Products, Inc. 1 0 2021-05-18
R&R Medical Corporation, Ltd. 1 0 2023-03-28
PR Personal Care Laboratories 1 1 2026-06-11
Bio-Tech Lubricants, Ltd. 1 0 2020-02-06
Boya Biotechnology Co., Ltd. 1 0 2020-12-23
Golden Isles Medical, Inc. 1 1 2026-04-16
Bath Concept Cosmetics (Dongguan) Co., Ltd. 1 0 2020-04-14
PCCA, Inc. 1 1 2026-07-06
Tyros Biopharma, Inc. 1 0 2024-03-01
Fidia Farmaceutici S.P.A. 1 0 2020-01-09
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-07 K261905 Bumlicious, LLC (DBA “Bumlicious”) BUM Oil
2026-07-09 K261177 PINKSLIP, LLC PINKSLIP Water-Based Personal Lubricant and Moisturizer
2026-07-06 K261909 PCCA, Inc. Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
2026-06-22 K254011 LBDO Group, Inc. Flow Water-Based Personal Lubricant
2026-06-11 K261292 PR Personal Care Laboratories PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
2026-06-09 K252914 Hathor Professional Skincare , Ltd. Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
2026-05-21 K260068 Pjur Group Luxembourg S.A. pjur NATURE Touch, 100 ml
2026-04-16 K254101 Golden Isles Medical, Inc. Julva Velvé Water-Based Personal Lubricant
2026-04-01 K260007 Hudi Pharma Srl Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
2026-03-06 K253983 Guangzhou Haoyimai Trading Co., Ltd. Water-based lubricant
2025-12-19 K251011 Unipack, LLC Chiavaye Personal Moisturizer
2025-12-15 K252935 Foshan Pingchuang Medical Technology Co., Ltd. Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
2025-12-12 K250488 Ansella Therapeutics Cerynë Intimate Care
2025-09-09 K251773 Shenzhen Yongquan Medical Devices Co., Ltd. Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
2025-08-08 K250142 Global Protection Corp. Water-based Lubricant
2025-08-08 K243972 Global Protection Corp. Plain Water-based Lubricant
2025-06-04 K242712 Sk Zen, LLC LubriZenzs
2025-05-09 K243107 Dongguan Yanxuan Biotechnology Co., Ltd. Water Solubility Human Body Lubricant
2025-05-02 K250629 Hathor Professional Skincare , Ltd. Sutil Rich Personal Lubricant
2025-03-20 K242958 Joylux, Inc. Joylux Intimacy Gel (PG3100)
2025-01-21 K241443 Hathor Professional Skincare , Ltd. 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)
2024-12-06 K242645 Project Chemistry, Inc. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
2024-09-27 K240745 Westridge Laboratories, Inc. ID Free Personal Lubricant
2024-09-19 K242162 Good Clean Love, Inc. Coconut Hybrid
2024-08-16 K240081 Jiangxi Wulinxiang Biological Technology Co., Ltd. Human Lubricant
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence