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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 K913776
Device Name PATIENT EXAMINATION GLOVES
Applicant
P.T. Irama Dinamika Latex
Jln. Hang Kesturi #8
Medan - Indonesia,  ID
Applicant Contact VENKATESAN
Correspondent
P.T. Irama Dinamika Latex
Jln. Hang Kesturi #8
Medan - Indonesia,  ID
Correspondent Contact VENKATESAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/13/1991
Decision Date 11/07/1991
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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