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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 K211239
Device Name Vinyl Patient Examination Gloves
Applicant
Jiangxi Shengda Medical Technology Co., Ltd.
#25 Factory, Wencheng Block, High-Tech Zone,
Yushan County
Shangrao,  CN 334711
Applicant Contact Yun Gao
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/26/2021
Decision Date 07/17/2021
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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