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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 K212661
Device Name Disposable Nitrile Examination Glove
Applicant
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
Room 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, No.161, East Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/23/2021
Decision Date 11/19/2021
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
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