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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 K980167
Device Name POWDERFREE LATEX EXAMINATION GLOVES
Applicant
Besglove Medicare Sdn. Bhd.
Lot Pt. 7177, Balakong N/V
Seri Kembangan
Selangor,  MY 43300
Applicant Contact LEE AIK LIM
Correspondent
Besglove Medicare Sdn. Bhd.
Lot Pt. 7177, Balakong N/V
Seri Kembangan
Selangor,  MY 43300
Correspondent Contact LEE AIK LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/16/1998
Decision Date 03/13/1998
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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