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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 K945948
Device Name ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES
Applicant
Ampri Rubberware Industries Sdn Bhd
Miel Phase Ii 44300 Batang
Kali
Selangor,  MY
Applicant Contact MAY PHNG
Correspondent
Ampri Rubberware Industries Sdn Bhd
Miel Phase Ii 44300 Batang
Kali
Selangor,  MY
Correspondent Contact MAY PHNG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/06/1994
Decision Date 07/31/1995
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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