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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 K894758
Device Name PATIENT LATEX EXAMINATION GLOVES
Applicant
Agrimal Industries Sdn. Bhd.
# 3, Jalan Songkit Sebelas
Taman Sentosa, 80150 Johor
Bahru, Johor, Malaysia,  MY
Applicant Contact CHEE SENG
Correspondent
Agrimal Industries Sdn. Bhd.
# 3, Jalan Songkit Sebelas
Taman Sentosa, 80150 Johor
Bahru, Johor, Malaysia,  MY
Correspondent Contact CHEE SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/26/1989
Decision Date 09/26/1989
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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