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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 K223250
Device Name Disposable Nitrile Examination Glove
Yangzhou Saraguard Medical Supplies Co.,Ltd.
Standard Workshop No. 1, Phase I, Comprehensive Bonded Zone
No. 9, Yangtze Jiangnan Road
Yangzhou,  CN 225009
Applicant Contact Guo Hua
Shanghai Truthful Information Technology Co., Ltd.
RM.1801, No.161, East Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
Date Received10/21/2022
Decision Date 01/19/2023
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