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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 K222815
Device Name Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Applicant
Zibo Lanhua Medical Packaging Material Co., Ltd.
# 21 Qingtian Rd., Xindian St.,
Zibo,  CN 255414
Applicant Contact Lily Wang
Correspondent
Zibo Lanhua Medical Packaging Material Co., Ltd.
# 21 Qingtian Rd., Xindian St.,
Zibo,  CN 255414
Correspondent Contact Lily Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received09/19/2022
Decision Date 12/04/2022
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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