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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K243959
Device Name Powder Free Nitrile Examination Gloves (Violet, Black, Green), 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 Chai Tinglong
Correspondent
Lingshi Hongruida Health Protection Technology Co., Ltd.
Yangjiayuan, Liangdu Town, Lingshi County
Jinzhong,  CN 031300
Correspondent Contact Chai Tinglong
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
OPJ   QDO  
Date Received12/23/2024
Decision Date 02/24/2025
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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