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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 K180849
Device Name Vinyl Examination Glove (Clear, Non-Colored)
Applicant
Huifu Trading Co., Ltd.
North Shanghai Rd. Zhangdian District
Zibo,  CN 255000
Applicant Contact Kangkang Wang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/02/2018
Decision Date 06/11/2018
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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