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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 K231365
Device Name Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
Applicant
Anhui Intco Medical Products Co., Ltd.
# 6, Haitang S. Rd., Suixi Wuhu Modern Industrial Park
Suixi County
Huaibei City,  CN 235000
Applicant Contact Max li
Correspondent
Intco Medical Industries, Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact Deze Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received05/11/2023
Decision Date 03/01/2024
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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