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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K220545
Device Name Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
Applicant
Hl Rubber Industries Sdn Bhd
Lot 10, Kawasan Perindustrian Dioh,
Kuala Pilah,  MY 72000
Applicant Contact Noorzaliza Ahmad
Correspondent
Hl Rubber Industries Sdn Bhd
Lot 10, Kawasan Perindustrian Dioh,
Kuala Pilah,  MY 72000
Correspondent Contact Noorzaliza Ahmad
Regulation Number880.6250
Classification Product Code
LZC  
Date Received02/25/2022
Decision Date 05/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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