NUC

Lubricant, Personal

产品代码
NUC
器械名称
Lubricant, Personal
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 884.5300
FDA 专业组
Obstetrics/Gynecology
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
31 件
其中 Summary 已存档
25 份,可直接下载
FDA 历史累计 510(k)
247 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(31 件)

数据窗口为最近三年。最新一件:2026-08-07。

510(k) 号批准日期申请人器械名称摘要
K2619052026-08-07Bumlicious, LLC (DBA “Bumlicious”)BUM OilPDF
K2611772026-07-09PINKSLIP, LLCPINKSLIP Water-Based Personal Lubricant and MoisturiPDF
K2619092026-07-06PCCA, Inc.Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriPDF
K2540112026-06-22LBDO Group, Inc.Flow Water-Based Personal LubricantPDF
K2612922026-06-11PR Personal Care LaboratoriesPR Water-Base Lube Personal Lubricant (PR Water-BasePDF
K2529142026-06-09Hathor Professional Skincare , Ltd.Sutil Pure Personal Lubricant (models 1148, 1145, 11PDF
K2600682026-05-21Pjur Group Luxembourg S.A.pjur NATURE Touch, 100 mlFDA
K2541012026-04-16Golden Isles Medical, Inc.Julva Velvé Water-Based Personal LubricantPDF
K2600072026-04-01Hudi Pharma SrlHyaluronic Acid Vaginal Suppository (HA 5 mg); HyaluPDF
K2539832026-03-06Guangzhou Haoyimai Trading Co., Ltd.Water-based lubricantPDF
K2510112025-12-19Unipack, LLCChiavaye Personal MoisturizerPDF
K2529352025-12-15Foshan Pingchuang Medical Technology CHybrid personal lubricant (water&silicone) (5ml, 8ml
K2504882025-12-12Ansella TherapeuticsCerynë Intimate CareFDA
K2517732025-09-09Shenzhen Yongquan Medical Devices Co.,Water-soluble Personal Lubricant (Satin Gel Vitamin PDF
K2501422025-08-08Global Protection Corp.Water-based Lubricant
K2439722025-08-08Global Protection Corp.Plain Water-based Lubricant
K2427122025-06-04Sk Zen, LLCLubriZenzsPDF
K2431072025-05-09Dongguan Yanxuan Biotechnology Co., LtWater Solubility Human Body LubricantPDF
K2506292025-05-02Hathor Professional Skincare , Ltd.Sutil Rich Personal LubricantPDF
K2429582025-03-20Joylux, Inc.Joylux Intimacy Gel (PG3100)PDF
K2414432025-01-21Hathor Professional Skincare , Ltd.Sutil Luxe Personal Lubricant (models 1126, 0009, 00PDF
K2426452024-12-06Project Chemistry, Inc.INA Moisturizing Intimate Lubricant Water-Based PersPDF
K2407452024-09-27Westridge Laboratories, Inc.ID Free Personal LubricantPDF
K2421622024-09-19Good Clean Love, Inc.Coconut HybridPDF
K2400812024-08-16Jiangxi Wulinxiang Biological TechnoloHuman LubricantPDF
K2340992024-06-07Select Labs, LLCSelect Hybrid Personal Lubricant, and Select Pure SiFDA
K2320402024-03-01Tyros Biopharma, Inc.GynatrofPDF
K2317942023-12-22Viramal LimitedElegant™ Advanced CompHortPDF
K2320932023-12-01Woo Essentials, Inc.Woo More Play Coconut Love OilPDF
K2320912023-10-22CC Wellness, LLCJO Coconut Hybrid Cooling Personal LubricantPDF
K2320902023-10-11CC Wellness, LLCJO Coconut Hybrid Warming Personal LubricantPDF

其中 25 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: NUC
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。