FDA.reportPublic FDA data

510(k) K253983

Device
Water-based lubricant
Applicant
Guangzhou Haoyimai Trading Co., Ltd.
510(k) number
K253983
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-06
Date received
2025-12-12
Regulation
884.5300
Classification name
Lubricant, Personal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Coco Ling
Address
10th Floor, Bldg. B, Shiliushe Industrial Zone Xiamao Shixia Rd., Baiyunhu St., Baiyun District Guangzhou CN 510000 510000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLC2026-07-09
K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.2026-07-06
K254011Flow Water-Based Personal LubricantLBDO Group, Inc.2026-06-22
K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories2026-06-11
K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.2026-06-09
K260068pjur NATURE Touch, 100 mlPjur Group Luxembourg S.A.2026-05-21
K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.2026-04-16
K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)Hudi Pharma Srl2026-04-01
K251011Chiavaye Personal MoisturizerUnipack, LLC2025-12-19
K252935Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)Foshan Pingchuang Medical Technology Co., Ltd.2025-12-15
K250488Cerynë Intimate CareAnsella Therapeutics2025-12-12
K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)Shenzhen Yongquan Medical Devices Co., Ltd.2025-09-09
K243972Plain Water-based LubricantGlobal Protection Corp.2025-08-08
K250142Water-based LubricantGlobal Protection Corp.2025-08-08
K242712LubriZenzsSk Zen, LLC2025-06-04