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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 K954487
Device Name PRE POWDERED LATEX EXAMINATION GLOVES
Applicant
Ganz Industries Sdn. Bhd.
Pt. # 3367, Jalan Am 2,
Arab Malaysian Ind. Pk.
Nilai, Negeri Sembilan,  MY 71800
Applicant Contact GAN SEONG KHIAM
Correspondent
Ganz Industries Sdn. Bhd.
Pt. # 3367, Jalan Am 2,
Arab Malaysian Ind. Pk.
Nilai, Negeri Sembilan,  MY 71800
Correspondent Contact GAN SEONG KHIAM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/27/1995
Decision Date 03/15/1996
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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