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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 K220834
Device Name Powder Free Nitrile Examination Glove
Applicant
DAXWELL, LLC
2825 Wilcrest Dr #500
Houston,  TX  77042
Applicant Contact Frank Zhang
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
LZA  
Date Received03/22/2022
Decision Date 06/29/2022
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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