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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 K220121
Device Name Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
Applicant
Aamedix Glove Sdn Bhd
Unit 19d, Level 19, #16, Persiaran Setia Dagang Bander
Setia Alam, 40170 Shah Alam
Selanger Darul Ehsan,  MY 40170
Applicant Contact Annette Schaps
Correspondent
Aamedix Glove Sdn Bhd
Unit 19d, Level 19, #16, Persiaran Setia Dagang Bander
Setia Alam, 40170 Shah Alam
Selanger Darul Ehsan,  MY 40170
Correspondent Contact Annette Schaps
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/18/2022
Decision Date 04/11/2022
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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