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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 K973801
Device Name HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
Applicant
Sri Johani Sdn. Bhd.
Lot Pt. 7178, Balakong N/V,
Seri Kembangan
Selangor,  MY 43300
Applicant Contact LIM L AIK
Correspondent
Sri Johani Sdn. Bhd.
Lot Pt. 7178, Balakong N/V,
Seri Kembangan
Selangor,  MY 43300
Correspondent Contact LIM L AIK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/06/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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