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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 K202356
Device Name Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Applicant
Kanglongda Vietnam Protection Technology Company Limited
Lot Cn 05, Viglacera-Phong Dien Industrial Park,
Phong Hoa Commune
Phong Dien,  VN 535041
Applicant Contact Lu Lingfeng
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/19/2020
Decision Date 03/02/2021
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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