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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 K946056
Device Name ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)
Applicant
Ampri Rubberware Industries Sdn Bhd
Lot 10, Unit Type A, Kawasan
Miel Phase Ii 4300 Batang Kali
Selangor,  MY
Applicant Contact MAY PHNG
Correspondent
Ampri Rubberware Industries Sdn Bhd
Lot 10, Unit Type A, Kawasan
Miel Phase Ii 4300 Batang Kali
Selangor,  MY
Correspondent Contact MAY PHNG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/06/1994
Decision Date 07/20/1995
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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