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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K210898
Device Name Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
Applicant
Tangshan Lanhai Medical Supplies Co., Ltd.
South Side Of Zhongda St., E. Side Of Jinxiu Rd.,
Chengxi Industrial Zone, Luannan County
Tangshan,  CN 063500
Applicant Contact Li Ruidong
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
LZA  
Date Received03/26/2021
Decision Date 08/26/2021
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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