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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 K222642
Device Name Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Applicant
Inner Mongolia Cureguard Medical Technology Co., Ltd.
Rm. 326, Management Committee Of New Industrial Park,
Tumote Youqi
Baotou,  CN 014100
Applicant Contact Guo Hua
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/01/2022
Decision Date 09/20/2022
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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