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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 K930995
Device Name POWDERED EXAMINATION GLOVES
Applicant
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Applicant Contact HANANTO
Correspondent
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Correspondent Contact HANANTO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/25/1993
Decision Date 08/16/1993
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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