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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 K240361
Device Name Power Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
Applicant
Hebei Titans Hongsen Medical Technology Co., Ltd.
Eastern Industrial Zone, Nangong City
Xingtai,  CN 051800
Applicant Contact Xiaojing Zhao
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 Received02/06/2024
Decision Date 04/04/2024
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
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