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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K252534
Device Name Surgical Face Mask (Ear mount)
Applicant
Zhejiang Hangkang Medical Equipment Co., Ltd.
4th Floor, Production Bldg. 2, # 633-1,
Jichang Rd., Beiyuan St.
Yiwu,  CN 322000
Applicant Contact Xiaocan Yan
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/12/2025
Decision Date 03/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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