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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 K213006
Device Name Vinyl Examination Gloves
Applicant
Taian Hengchang Medical Technology Co., Ltd.
#88 Central Rd., Sunbo Town Industrial Park In Feicheng
Taian City,  CN 271607
Applicant Contact Jing Li
Correspondent
Shanghai 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
LYZ  
Date Received09/20/2021
Decision Date 12/21/2021
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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