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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 K240824
Device Name Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
Applicant
Ningxia Qiaoen Medical Technology Co., Ltd.
300 Meters E. Of The Intersection Of Changtai Rd.
And Hongsheng E. Rd., Helan Industrial Park
Yinchuan,  CN 750220
Applicant Contact Johnson Liu
Correspondent
Ningxia Qiaoen Medical Technology Co., Ltd.
300 Meters E. Of The Intersection Of Changtai Rd.
And Hongsheng E. Rd., Helan Industrial Park
Yinchuan,  CN 750220
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/26/2024
Decision Date 06/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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