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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 K233042
Device Name Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Shandong Intco Medical Products Co, Ltd.
Qiwang Rd., Naoshan Industrial Park
Qingzhou,  CN 2625000
Applicant Contact Max Li
Correspondent
Shandong Intco Medical Products Co, Ltd.
Qiwang Rd., Naoshan Industrial Park
Qingzhou,  CN 2625000
Correspondent Contact Max Li
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received09/25/2023
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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