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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 K182089
Device Name Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
Applicant
Platinum Glove Industries Sdn. Bhd.
Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar
Selangor Darul Ehsan,  MY 42100
Applicant Contact Foo Khon Pu
Correspondent
Platinum Glove Industries Sdn. Bhd.
Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar
Selangor Darul Ehsan,  MY 42100
Correspondent Contact Poppy Farah Rosa
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/02/2018
Decision Date 07/30/2019
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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