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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K211229
Device Name Vinyl compound examination gloves
Applicant
Hebei Titans Hongsen Medical Technology Co., LTD.
Eastern Industrial Zone
Nangong,  CN 051800
Applicant Contact Feng Shuangyan
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm. 912, Building 15, XiYueHui, No. 5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/23/2021
Decision Date 07/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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