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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 K213107
Device Name Powder Free Blue Nitrile Examination Gloves
Applicant
Novid Ppe Sdn. Bhd.
Lot 6071, Jalan Haji Abdul Manan, Batu 5 1/2,
Jalan Meru
Klang,  MY 41050
Applicant Contact Er Chai Chuan
Correspondent
Novid Ppe Sdn. Bhd.
Lot 6071, Jalan Haji Abdul Manan, Batu 5 1/2,
Jalan Meru
Klang,  MY 41050
Correspondent Contact Er Chai Chuan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/24/2021
Decision Date 02/17/2022
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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