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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 K211581
Device Name Disposable Nitrile Examination Gloves (Powder free, Blue)
Applicant
Leping Shengde Medical Technology Company Limited
#17, Yubao Village, Lingang Village Committee, Lingang
Town, Leping City
Jingdezhen,  CN 333300
Applicant Contact Sheng Jianchao
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 Received05/21/2021
Decision Date 10/28/2021
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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