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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K892176
Device Name CORRECT TOUCH SURGEONS GLOVES
Applicant
Ampri Rubberware Industries Sdn Bhd
Magnum Plz., Suite 801, 8th
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Applicant Contact MAY PHNG
Correspondent
Ampri Rubberware Industries Sdn Bhd
Magnum Plz., Suite 801, 8th
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Correspondent Contact MAY PHNG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/05/1989
Decision Date 09/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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