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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 K892175
Device Name CORRECT TOUCH EXAMINATION GLOVES (LATEX)
Applicant
Ampri Rubberware Industries Sdn Bhd
Magnum Plz., Suite 801, 8th
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Applicant Contact JIMMY CHIEW
Correspondent
Ampri Rubberware Industries Sdn Bhd
Magnum Plz., Suite 801, 8th
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Correspondent Contact JIMMY CHIEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 08/25/1989
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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