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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 K032011
Device Name GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
Applicant
Pt. Wrp Buana Multicorpora
Jalan Jermal #20b, Kelurahan
Sei Mati, Medan Labuhan Km 17
Medan,  ID 20252
Applicant Contact NG POY SIN
Correspondent
Pt. Wrp Buana Multicorpora
Jalan Jermal #20b, Kelurahan
Sei Mati, Medan Labuhan Km 17
Medan,  ID 20252
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/30/2003
Decision Date 08/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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