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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 K213437
Device Name Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
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  
Subsequent Product Codes
LZC   QDO  
Date Received10/22/2021
Decision Date 04/11/2022
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
Predetermined Change
Control Plan Authorized		 No
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