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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 K892074
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Perusahaan Intan Emas Sdn. Bhd.
Lot Pt. 153, Kawasan
Perusahaan Beranang, Mukim
Beranang, Selangor, D.E.,  MY 43700
Applicant Contact LONG NIEN
Correspondent
Perusahaan Intan Emas Sdn. Bhd.
Lot Pt. 153, Kawasan
Perusahaan Beranang, Mukim
Beranang, Selangor, D.E.,  MY 43700
Correspondent Contact LONG NIEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 04/28/1989
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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