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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 K223415
Device Name Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Applicant Contact Ivan Tan Chee Wei
Correspondent
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Correspondent Contact Ivan Tan Chee Wei
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received11/10/2022
Decision Date 01/26/2023
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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