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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 K901855
Device Name LATEX PATIENT EXAMINATION GLOVE
Applicant
Tower Marketing Sdn. Bhd.
Lot 2.10, 2nd Floor, Wisma
Angkasaraya, Jalan Ampang
50450 Kuala Lumpur,  MY
Applicant Contact PETER TAN
Correspondent
Tower Marketing Sdn. Bhd.
Lot 2.10, 2nd Floor, Wisma
Angkasaraya, Jalan Ampang
50450 Kuala Lumpur,  MY
Correspondent Contact PETER TAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/24/1990
Decision Date 05/18/1990
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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