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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 K891428
Device Name PATIENT EXAMINATION GLOVES (LATEX) (POWDERED)
Applicant
Bio-Aid Industries Sdn Bhd
9 Jalan Gagah, Larkin
Industrial Estate
Johor Bahru,  MY 80350
Applicant Contact MOHAN GANGARAM
Correspondent
Bio-Aid Industries Sdn Bhd
9 Jalan Gagah, Larkin
Industrial Estate
Johor Bahru,  MY 80350
Correspondent Contact MOHAN GANGARAM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/14/1989
Decision Date 05/11/1989
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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