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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 K212535
Device Name Nitrile Powder Free Blue Examination Gloves, Non-Sterile
Applicant
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Applicant Contact Azlan Hashim
Correspondent
Mah Sing Healthcare Sdn. Bhd.
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur,  MY 57100
Correspondent Contact Azlan Hashim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/11/2021
Decision Date 12/04/2021
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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