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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 K991554
Device Name GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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
LYY  
Date Received05/03/1999
Decision Date 07/09/1999
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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