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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K011293
Device Name POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
Applicant
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Applicant Contact ABD HADI BIN HUSIN
Correspondent
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Correspondent Contact ABD HADI BIN HUSIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/30/2001
Decision Date 07/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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