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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 K220609
Device Name Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Applicant
Encompass Industries Sdn. Bhd.
Lot 18256, Kawasan Perindustrian Lot Q
Kertih BioPolymer Park
Kemaman,  MY 24300
Applicant Contact Nur Atikah binti Muhammad Muhyiddin
Correspondent
Encompass Industries Sdn. Bhd.
Lot 18256, Kawasan Perindustrian Lot Q
Kertih BioPolymer Park
Kemaman,  MY 24300
Correspondent Contact Nur Atikah binti Muhammad Muhyiddin
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/02/2022
Decision Date 05/27/2022
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
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