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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 K931406
Device Name POWDER-FREE PATIENT EXAMINATION GLOVES
Applicant
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Applicant Contact SEONG LEE
Correspondent
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Correspondent Contact SEONG LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/19/1993
Decision Date 10/21/1993
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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