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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 K240051
Device Name Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Applicant
Lingshi Hongruida Health Protection Technology Co., Ltd.
Yangjiayuan, Liangdu Town, Lingshi County
Jinzhong,  CN 031300
Applicant Contact Tinglong Chai
Correspondent
Lingshi Hongruida Health Protection Technology Co., Ltd.
Yangjiayuan, Liangdu Town, Lingshi County
Jinzhong,  CN 031300
Correspondent Contact Tinglong Chai
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received01/08/2024
Decision Date 02/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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