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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 K211103
Device Name Powder Free Vinyl Examination Gloves
Applicant
Shanghai Shengda Medical Applications Co., Ltd.
# 608 Xingwen Rd., N. Development Zone,
Jiading District
Shanghai,  CN 201815
Applicant Contact Ying Su
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/13/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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