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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 K952833
Device Name AMPRI
Applicant
Ampri Rubberware Industries Sdn Bhd
Unit Type A, Lot 10
Kawasan Mikel, Batang Kali,
Phase Ii 44300 Batang Kali,  MY
Applicant Contact MIKE SCOLARI
Correspondent
Ampri Rubberware Industries Sdn Bhd
Unit Type A, Lot 10
Kawasan Mikel, Batang Kali,
Phase Ii 44300 Batang Kali,  MY
Correspondent Contact MIKE SCOLARI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/20/1995
Decision Date 09/05/1995
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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