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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 K211310
Device Name AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Applicant
Megine Industries Sdn Bhd
B-05-02, The Vertical Business Suites, 8,
Jalan Kerinchi, Bangsar S.
Kuala Lumpur,  MY 59200
Applicant Contact Benjamin Ng Soong Jing
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/30/2021
Decision Date 06/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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