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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 K961675
Device Name BG PATIENT EXAMINATION GLOVES, NON-STERILE
Applicant
Biografik (Malaysia) Sdn Bhd
Pt 3307 Jalan Am 1
Arab-Malaysian Industrial Park
Nilai, Negeri Sembilan,  MY 71800
Applicant Contact A K WONG
Correspondent
Biografik (Malaysia) Sdn Bhd
Pt 3307 Jalan Am 1
Arab-Malaysian Industrial Park
Nilai, Negeri Sembilan,  MY 71800
Correspondent Contact A K WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/26/1996
Decision Date 07/25/1996
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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