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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K981878
Device Name POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
Applicant
BESGLOVE MEDICARE SDN. BHD.
LOT 6, JALAN P/2A, BANGI INDUS
ESTATE, 43650 BANDAR BARU BANG
SELANGOR DARUL EHSAN,  MY
Applicant Contact LEE AIK LIM
Correspondent
BESGLOVE MEDICARE SDN. BHD.
LOT 6, JALAN P/2A, BANGI INDUS
ESTATE, 43650 BANDAR BARU BANG
SELANGOR DARUL EHSAN,  MY
Correspondent Contact LEE AIK LIM
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/28/1998
Decision Date 08/11/1998
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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