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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 K894773
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Transrich Industries Sdn. Bhd.
Wisma Sama, Lot 26, Jalan
223/51a
Petaling Jaya Selang,  MY 46100
Applicant Contact KEN SOO
Correspondent
Transrich Industries Sdn. Bhd.
Wisma Sama, Lot 26, Jalan
223/51a
Petaling Jaya Selang,  MY 46100
Correspondent Contact KEN SOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/26/1989
Decision Date 08/29/1989
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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