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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 K000838
Device Name DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS 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 Received03/14/2000
Decision Date 10/23/2000
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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