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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 K220232
Device Name 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 South
Kuala Lumpur,  MY 59200
Applicant Contact Benjamin Ng Soong Jing
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/27/2022
Decision Date 02/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party Yes
Combination Product No
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