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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 K220066
Device Name Medical Nitrile Examination Gloves
Applicant
Hunan Zhenheyikang Medical Instrument Co., Ltd.
#6 Bldg. Jingxiang Energy,#55 Xiaguang E. Rd.,
Gaoxin District
Xiangtan,  CN 411100
Applicant Contact Yilin Yin
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
LZA  
Date Received01/10/2022
Decision Date 04/03/2022
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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