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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 K945505
Device Name ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE
Applicant
Ganz Industries Sdn. Bhd.
Pt # 3367, Jalan Am 2
Arab Malaysian Industrial Park
Nilai 71800, Negeri Sembilan,  MY
Correspondent
Ganz Industries Sdn. Bhd.
Pt # 3367, Jalan Am 2
Arab Malaysian Industrial Park
Nilai 71800, Negeri Sembilan,  MY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/09/1994
Decision Date 08/18/1995
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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