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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 K000999
Device Name MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
MULTISAFE SDN BHD
LOT 764
BIDOR INDUSTRIAL ESTATE
35500 BIDOR, PERAK,  MY 35500
Applicant Contact ABD. HADI BIN HUSIN
Correspondent
MULTISAFE SDN BHD
LOT 764
BIDOR INDUSTRIAL ESTATE
35500 BIDOR, PERAK,  MY 35500
Correspondent Contact ABD. HADI BIN HUSIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/2000
Decision Date 05/22/2000
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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