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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
Predetermined Change
Control Plan Authorized		 No
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