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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 K203036
Device Name Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
Applicant
Central Medicare Sdn Bhd
PT 2609-2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact Fatin Nor Irdina Bt Ahmad Fauzi
Correspondent
Central Medicare Sdn Bhd
PT 2609-2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Correspondent Contact Fatin Nor Irdina Bt Ahmad Fauzi
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/05/2020
Decision Date 05/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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