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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 K013163
Device Name UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
N.S. Uni-Gloves Sdn. Bhd.
Ug Healthcare (Usa) Inc
2420 Carson St. Suite 125
Torrance,  CA  90501
Applicant Contact ROBERT D VANDER LEEK
Correspondent
N.S. Uni-Gloves Sdn. Bhd.
Ug Healthcare (Usa) Inc
2420 Carson St. Suite 125
Torrance,  CA  90501
Correspondent Contact ROBERT D VANDER LEEK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/21/2001
Decision Date 01/22/2002
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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