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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 K010881
Device Name UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
N.S. Uni-Gloves Sdn. Bhd.
Ug Healthcare (Usa) Inc
2420 Carson St. Suite 125
Torrance,  CA  90501
Applicant Contact ROBERT D VANDER
Correspondent
N.S. Uni-Gloves Sdn. Bhd.
Ug Healthcare (Usa) Inc
2420 Carson St. Suite 125
Torrance,  CA  90501
Correspondent Contact ROBERT D VANDER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/2001
Decision Date 05/16/2001
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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