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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K253983
Device Name Water-based lubricant
Applicant
Guangzhou Haoyimai Trading Co., Ltd.
10th Floor, Bldg. B, Shiliushe Industrial Zone
Xiamao Shixia Rd., Baiyunhu St., Baiyun District
Guangzhou,  CN 510000
Applicant Contact Coco Ling
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Aria Yao
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/12/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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