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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 K945506
Device Name ACRYLIC DIPPED LATEX EXAMINATION GLOVES
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 Number880.6250
Classification Product Code
LYY  
Date Received11/09/1994
Decision Date 10/12/1995
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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