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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 K941754
Device Name POWDER FREE LATEX EXMINATION GLOVES
Applicant
Sj Medical Products (M) Sdn Bhd
Lot 723, 5 1/2 Miles,
Jalan Kapar
Klang, Selangor,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
Sj Medical Products (M) Sdn Bhd
Lot 723, 5 1/2 Miles,
Jalan Kapar
Klang, Selangor,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/08/1994
Decision Date 05/09/1994
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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