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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 K941787
Device Name LATEX EXAM GLOVES
Applicant
P.T. Irama Dinamika Latex
Jl. Kapten Pattimura # 23/
235 Medan 21053
Indonesia,  ID
Applicant Contact ANIL TANEJA
Correspondent
P.T. Irama Dinamika Latex
Jl. Kapten Pattimura # 23/
235 Medan 21053
Indonesia,  ID
Correspondent Contact ANIL TANEJA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1994
Decision Date 10/19/1994
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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