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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 K021308
Device Name GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
Applicant
Glovco (M) Sdn. Bhd.
Lot 760(Block A),Jalan Haji
Sirat Off Jalan Meru
Klang, Selangor D.E.,  MY 42100
Applicant Contact TAN PENG HOCK
Correspondent
Glovco (M) Sdn. Bhd.
Lot 760(Block A),Jalan Haji
Sirat Off Jalan Meru
Klang, Selangor D.E.,  MY 42100
Correspondent Contact TAN PENG HOCK
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/25/2002
Decision Date 05/14/2002
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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