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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 K021659
Device Name PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
Applicant
P.T. Healthcare Glovindo
Jl. Kol. Yos Sudarso K.M. 10
Kawasan Indusri Medan
Medan,  ID 10340
Applicant Contact ELLEN HUTAPEA
Correspondent
P.T. Healthcare Glovindo
Jl. Kol. Yos Sudarso K.M. 10
Kawasan Indusri Medan
Medan,  ID 10340
Correspondent Contact ELLEN HUTAPEA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/20/2002
Decision Date 08/12/2002
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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