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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 K212833
Device Name Disposable Nitrile Examination Gloves
Applicant
Chifeng Huawei Medical Science&Technology Co., Ltd.
# 2-4, Second-Stage Standardized Plant, Songshan
(Anqing) Industrial Park
Chifeng,  CN 024023
Applicant Contact Li Xiaohong
Correspondent
Shanhai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/07/2021
Decision Date 02/28/2022
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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