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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vinyl patient examination glove
510(k) Number K220469
Device Name Disposable Vinyl Examination Glove
Applicant
Chifeng Huawei Medical Science&Technology Co.,Ltd.
No. 2-4, Second-stage Standardized Plant, Songshan
(Anqing) Industrial Park
Chifeng,  CN 024023
Applicant Contact Li Xiaohong
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.1801,No.161 Lujiazui East Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/18/2022
Decision Date 06/16/2022
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
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