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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 K894677
Device Name LATEX EXAMINATION GLOVES
Applicant
Kumpulan Santra (Penang) Sdn. Bhd.
109, 1st Floor , Renong Westcourt
126, Jalan Kelang Lama, 58000
Kuala Lumpur, Malaysia,  MY
Applicant Contact FRANCIS KHOO
Correspondent
Kumpulan Santra (Penang) Sdn. Bhd.
109, 1st Floor , Renong Westcourt
126, Jalan Kelang Lama, 58000
Kuala Lumpur, Malaysia,  MY
Correspondent Contact FRANCIS KHOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/24/1989
Decision Date 10/04/1989
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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