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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 K212834
Device Name Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Applicant
Siyang Threeguard Medical Supplies Co., Ltd.
East Of Nanhai Rd. And S. Of Guilin Rd.,
Economic Development Zone, Siyang County
Suqian,  CN 223799
Applicant Contact Guo Hua
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.1801,#161,East Lu Jiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/07/2021
Decision Date 12/30/2021
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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