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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 K214110
Device Name Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
Applicant
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Applicant Contact Sazalinda Musa
Correspondent
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Correspondent Contact Sazalinda Musa
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received12/29/2021
Decision Date 02/19/2022
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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