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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 K012876
Device Name DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot 11, Jalan 2, Kawasan
Perusahaan Bandar Baru, Salak
Tinggi, Sepang, Selangor,  MY 43900
Applicant Contact MOHD HAIZAN HUSSEIN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot 11, Jalan 2, Kawasan
Perusahaan Bandar Baru, Salak
Tinggi, Sepang, Selangor,  MY 43900
Correspondent Contact MOHD HAIZAN HUSSEIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/27/2001
Decision Date 10/01/2001
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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