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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 K212924
Device Name Nitrile Examination Gloves
Applicant
Shanxi Nacosa Medical Technology Co.,Ltd
Chengxi Industrial Park, Wenxi Economic And Technological
Development Zone
Yuncheng City,  CN 043800
Applicant Contact Lu Yingying
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 Received09/14/2021
Decision Date 12/13/2021
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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