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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K010232
Device Name PRE-POWDERED NITRILE EXAMINATION GLOVES
Applicant
P.T. Healthcare Glovindo
Jl. Kol. Yos Sudarso K.M. 10
Kawasan Indusri Medan (Kim)
Medan 10340,  ID 10340
Applicant Contact ELLEN HUTAPEA
Correspondent
P.T. Healthcare Glovindo
Jl. Kol. Yos Sudarso K.M. 10
Kawasan Indusri Medan (Kim)
Medan 10340,  ID 10340
Correspondent Contact ELLEN HUTAPEA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/24/2001
Decision Date 09/21/2001
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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